20 April 2022, Volume 36 Issue 2(S2)
    

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  • Editorial
    S.E. Aragona, G. Ciprandi
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 1-2. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.1
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  • Editorial
    S.E. Aragona, G. Ciprandi
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 3-7. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.2
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  • Article
    M. Gelardi, I. La Mantia, S.E. Aragona, G. Cupido, G. G. Ciprandi, the Italian Study Group on Upper Respiratory Infections
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 9-14. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.3
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    Upper respiratory infections represent a common problem in clinical practice. Doctors very frequently use antibiotics in managing infections. However, antibiotics alter the physiological microbiota, causing dysbiosis. Dysbiosis worsens respiratory symptoms, changes gut function, amplifies inflammation, and impairs the immune response. Probiotics significantly restore respiratory and gut microbiota, expediting recovery and preventing relapse. In this regard, a probiotic mixture (Abincol@), containing Lactobacillus plantarum LP01, Lactobacillus lactis subspecies cremoris LLC02, and Lactobacillus delbrueckii subspecies delbrueckii LDD01, is fruitfully used in common practice. Recently, a new multi-component food supplement (Abincol Immuno®) has been launched.This product contains an innovative probiotic mixture (Lactobacillus plantarum, Lactobacillus rhamnosus, and Lactobacillus delbrueckii subsp. Bulgaricus), zinc, inulin, and vitamin D. This product has been tested in a practical experience by a panel of Italian otorhinolaryngologists who visited a large number of patients with upper airways infections. All patients were treated with antibiotics and Abincol@ for two weeks, then a subgroup (ratio 1:1) took a one-month course of Abincol Immuno® (Group A), the other patients served as control (Group B). Patients were evaluated at baseline (T0), at the end of antibiotic treatment (T1), at the end of the Abincol Immuno® course (T2), and at the end of 4-month follow-up (T3). Globally, 3.819 outpatients (mean age 45 years) were enrolled: 1.936 (50.7%) in Group A and 1.883 (49.3%) in Group B. This food supplement significantly reduced the rate of patients with cough (p=0.03), fatigue (p<0.001), headache (p<0.01), and malaise (p=0.01). Both food supplements were well tolerated, and no significant adverse reactions were observed. In conclusion, the current clinical experience suggested that immune manipulation with this ulti-component product may be considered an effective and safe therapeutic option in managing patients with an upper respiratory infection and treated with antibiotics.

  • Case Report
    I. La Mantia, M. Gelardi, S.E. Aragona, G. Cupido, G. Ciprandi, the Italian Study Group on Upper Respiratory Infections
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 15-21. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.4
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    Acute rhinosinusitis (ARS) affects the nose and paranasal sinuses together. Acute rhinosinusitis is usually suspected on the clinical ground, but the diagnosis is confirmed by endoscopy. Antibiotic therapy is used for ARS patients in almost all patients. However, antibiotics induce dysbiosis, such as a disturbed balance of physiological microbiota. Dysbiosis impairs the immune system and slows down the resolution of inflammatory events consequent to the infection. The current clinical experience was conducted in patients with ARS visited in an otolaryngologic setting. All patients were treated with antibiotics and Abincol@ for two weeks, then a subgroup (ratio 1:1) took a one-month course of Abincol Immuno® (Group A), the other patients served as control (Group B). Patients were evaluated at baseline (T0), at the end of antibiotic treatment (T1), at the end of the Abincol Immuno® course (T2), and at the end of 4-month follow-up (T3). Globally, 601 outpatients (mean age 46 years) were enrolled: 305 (50.7%) in Group A and 296 (49.3%) in Group B. The baseline data were superimposable in the two groups, so the groups were well-matched. At T2, Group A patients had a lower frequency of cough (p=0.05), fatigue (p=0.04), and nausea (p=0.02). However, there was no difference in the symptom severity between groups, even if Group A patients experienced fewer symptoms than controls. In conclusion, the present clinical experience demonstrated that immune manipulation with this multi-component product might be considered an effective and safe therapeutic option in managing patients with acute rhinosinusitis and treated with antibiotics.

  • Case Report
    I. La Mantia, M. Gelardi, S.E. Aragona, G. Cupido, G. Ciprandi, the Italian Study Group on Upper Respiratory Infections
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 23-28. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.5
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    Acute pharyngotonsillitis is a common disease, mainly characterized by a sore throat. The diagnosis is usually performed on the clinical ground, and antibiotic therapy is frequently used in clinical practice on an empirical basis. Antibiotics frequently induce intestinal and respiratory dysbiosis associated with slow recovery. Therefore, probiotics are commonly prescribed in patients treated with antibiotics to restore the physiological microbiota. The current clinical experience was conducted in patients with acute pharyngotonsillitis and treated with antibiotics. All patients were treated with antibiotics and Abincol@for two weeks, then a subgroup (ratio 1:1) took a one-month course of Abincol Immuno® (Group A), the other patients served as control (Group B). Patients were evaluated at baseline (T0), at the end of antibiotic treatment (T1), at the end of the Abincol Immuno® course (T2), and at the end of 4-month follow-up (T3).Globally, 922 outpatients (mean age 46 years) were enrolled: 452 (49%) in Group A and 470 (51%) in Group B. At T2, Group A patients had a lower frequency of all symptoms. Both nutraceuticals were well tolerated. In conclusion, the present clinical experience demonstrated that immune manipulation with this innovative multi-component product might be considered an effective and safe therapeutic option in managing patients with acute pharyngotonsillitis and treated with antibiotics.

  • Article
    M. Gelardi, I. La Mantia, S.E. Aragona, G. Cupido, G. Ciprandi, the Italian Study Group on Upper Respiratory Infections
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 29-35. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.6
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    Acute otitis media (AOM) affects the middle ear and is clinically characterized by earache as the main symptom. Otitis media may be clinically suspected, but the otoscopy usually confirms the diagnosis. Antibiotic therapy is used in clinical practice, primarily in patients with severe symptoms. However,antibiotics often induce intestinal and respiratory dysbiosis associated with some clinical problems.Dysbiosis impairs the immune system and slows down the resolution of inflammatory events consequent to the infection. The current clinical experience was conducted in patients with AOM and taking antibiotics.All patients were treated with antibiotics and Abincol@ for two weeks, then a subgroup (ratio 1:1) took a one-month course of Abincol Immuno® (Group A), the remaining patients served as control (Group B). Patients were evaluated at baseline (T0), at the end of antibiotic treatment (T1), at the end of the AbincolImmuno® course (T2), and at the end of 4-month follow-up (T3). Globally, 821 outpatients (mean age 46 years) were enrolled: 389 (47.4%) in Group A and 432 (52.6%) in Group B. At T2, Group A patients had a lower frequency of fatigue (p=0.02) and pain (p=0.01). However, there was no difference in the symptom severity between groups, even if Group A patients experienced more minor symptoms than controls. In conclusion, the present clinical experience demonstrated that immune manipulation with this new multicomponent product might be considered an effective and safe therapeutic option in managing patients with acute otitis media and treated with antibiotics.

  • Article
    S.E. Aragona, M.E. Baldassarre, S. Lazzaro, G. Ciprandi
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 37-40. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.7
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    Gastric reflux, such as the spill of gastric contents outside the stomach, may become symptomatic when the refluxate damages the esophageal mucosa, such as the gastroesophageal reflux disease (GERD). The worldwide prevalence of GERD is continuously increasing in the last few years. The guidelines for diagnosing and treating GERD are well consolidated and timely updated. In addition, gastric content, even only gaseous, may spill out the esophagus, damaging other organs, mainly airways. As a result,the extra-esophageal manifestations of reflux have been considered from a multidisciplinary point of view; the symptoms of laryngopharyngeal reflux (LPR) are precisely defined as autonomous disorders.The otolaryngologists have codified guidelines for the LPR diagnosis, but the treatment is still poorly specified. Consequently, many healthcare professionals, including general practitioners, pediatricians, gastroenterologists, otolaryngologists, other medical specialists, and pharmacists, manage GERD and LPR patients. Many therapeutic options are available. The most common medications include proton pump inhibitors, alginates, and antacids.

  • Article
    S.E. Aragona, G. Ciprandi
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 41-45. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.8
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    Gastroesophageal reflux disease (GERD) is a widespread disease, as about a quarter of the Western population has GERD symptoms at least weekly, and GERD is the most frequent reason for outpatient gastroenterology consultation. Laryngopharyngeal reflux (LPR) is the extra-oesophageal counterpart of GERD, as the upper airways are the target of the extraesophageal spill out of gastric contents. GERD and LPR treatment are commonly based on proton pump inhibitor (PPI) use, but PPI may be ineffective in some patients and potentially unsafe if administered for a very long time. As a result, other therapeutic options include alginates and antacids. Most of the compounds used for managing gastric reflux are available as over the counter products or medical devices. Thus, pharmacist plays an active role in advising these products. The current experience resulted from the involvement of a group of Italian pharmacists who participated in an educational project on managing gastric reflux problems. This experience, involving 372 Italian pharmacies, provided some interesting findings. First, 63% of subjects visiting a pharmacy required treatment for GERD, and 38% had LPR. Moreover, more than 40% of subjects did not follow a correct diet or adequate gastric reflux lifestyle. In this regard, the pharmacist advised a diet and lifestyle change in 43% of subjects as a first-line option. PPI was the most common medication, both as monotherapy or polytherapy, about past or concomitant treatment for gastric reflux symptoms. Alginates were the second choice as both alone or add-on. Very notably, the updating of the knowledge about gastric reflux significantly affected the attitude of pharmacists to advise OTC products. As a result, there was a reduction of PPI suggestions and increased alginates. In particular, the combined strategy, such as the PPI add-on to alginates, was the most common option.

  • Article
    S.E. Aragona, M.E. Baldassarre, G. Ciprandi
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 47-51. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.9
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    Gastroesophageal reflux (GER)in infants is the most common causes for physician consultation worldwide. Moreover, GER disease (GERD) also affects children. In addition, laryngopharyngeal reflux (LPR) may also affect children. As a result, the pediatrician has to often manage these diseases in daily practice. An educational program concerning updating knowledge about this issue was performed in a panel of 246 Italian pediatricians. The prescriptive attitude was assessed before and after the educational course. History, mainly regarding treatments, Infant Gastroesophageal Reflux Questionnaire (I-GERQ),GERD-Q, and reflux symptom index (RSI) were administered. The group of infants included 1,800 infants.The group of children included 1,706 subjects. There was a shift for monot herapy in infants’ management from 86.3% to 96%. In particular, the quote of alginate monotherapy increased from 79% to 94%. On the contrary, proton pump inhibitor (PPI) monotherapy decreased from 17.5% to 5%. Polytherapy substantially did not change. There was a shift for monotherapy from 74% to 88.4% in children’s management. In particular, the quote of alginate monotherapy increased from 34% to 65.3%.On the contrary, PPI monotherapy decreased from 30% to 10.7%. Polytherapy substantially did not change.In conclusion, the current experience demonstrated that GERD is a widespread medical problem in infants andchildren, and LPR significantly affects children. Updating the knowledge on gastric reflux significantly changed the prescriptive attitude of pediatricians. Alginates were the most common substance used in managing infants and children with gastric reflux. Therefore, PPI is used mostly combined with alginates.

  • Article
    S.E. Aragona, M.E. Baldassarre, G. Ciprandi
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 53-57. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.10
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    Gastroesophageal Reflux (GER) is a common disease; if associated with oesophageal damage is named GER disease (GERD) or if it damages upper airways as laryngopharyngeal Reflux (LPR). Although gastric reflux is common, its management remains challenging at the primary care level. The current experience evaluated the impact of an educational project about gastric reflux on the prescriptive attitude of primary care doctors. A large group of patients (20,778) with gastric reflux symptoms was evaluated before and after the educational program, involving 708 Italian physicians working at the primary care level. Before the update, only one-quarter of patients were actively treated for gastric reflux problems. The most common medications were PPI (72%), alginates (40%), and antacids (33%). A monotherapy was more frequently prescribed than polytherapy. After the educational program, 71% of patients had GERD diagnosis, and 29% LPR. In addition, 84% of patients had a medical prescription for harmful gastric reflux. Polytherapy was prescribed in 9,422 patients, mainly using PPI as an add-on associated with alginates, prokinetics, or antacids. Monotherapy was used in 8,069 patients, alginates were prescribed in 52% of patients, PPI in 28.6%, and antacids in 9.4%. In conclusion, the current experience confirmed the worth of continuing medical education and the importance of correctly managing patients with gastric reflux concerns. GERD and LPR should be adequately treated using appropriate medications, mainly concerning alginates and PPI.

  • Article
    S.E. Aragona, L. Pasquale, P. Fedeli, G. Galloro, P. Da Massa Carrara, D. Iannuzziello, P. Paiano, E. Savarino, M. Vinti, G. Ciprandi
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 59-64. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.11
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    Diverticular disease is a common medical problem, mainly affecting older people. Different phenotypes have been described, including symptomatic diverticular disease, diverticulitis, symptomatic uncomplicated diverticular disease (SUDD), and segmental colitis associated with diverticulosis (SCAD).The management of diverticular disease consists of antibiotics and anti-inflammatory drugs that should be used for very long times. However, side effects commonly occur. Therefore, a new multi-component food supplement (Divercol®) has been recently launched to be employed in these patients. This product contains seeds of Plantago psyllium, dry extract of Perilla frutescens, Citrus paradisi seeds dry extract, a mixture of tyndallized probiotics (Lactobacillus rhamnosus, L reuteri, L acidophilus), and riboflavin. The recent experience evaluated its preventive and adjunctive activity in 388 patients with SUDD, symptomatic diverticular disease, and diverticular disease and treated with multiple antibiotic courses.Patients took a one-week antibiotic course, then a two-week Divercol® course (one stick/day). The assessed symptoms included: intestinal movement alteration, meteorism/flatulence, and abdominal pain. The visual analogue scale measured patients’ perception of symptoms. All patients perceived a significant (p<0.001 at all times) improvement of all measured parameters. In addition, the treatment was safely tolerated.In conclusion, the current clinical experience suggested that the multi-component product Divercol®may be an effective and safe adjunctive therapeutic option in managing patients with diverticular disease.

  • Article
    S.E. Aragona, V. Camesasca, S. Lazzaro, G. Ciprandi
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 65-69. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.12
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    Rhinitis is an inflammatory disease of the nose. The rhinitis classification considers different phenotypes characterized by the etiopathogenic mechanisms. The most common types include infectious rhinitis, allergic rhinitis, non-allergic rhinitis, vasomotor rhinitis, atrophic rhinitis, medicamentosa (iatrogenic)rhinitis, and hormonal rhinitis. Natural remedies are even more esteemed and requested by the patients.In this regard, Rinalt® is a Medical Device Class II CE formulated as a nasal spray. Rinalt® contains Mucotannil® complex, seawater, dexpanthenol, and essential balsamic oils. Rinalt® is an adjunctive treatment for respiratory disorders characterized by mucus hyperproduction, including infectious rhinitis and allergic rhinitis. This formulation results in a protective barrier against pathogens, allergens, irritants, and noxious substances. These effects are obtained thanks to the active components. Its components exert many activities, including antimicrobial, anti-inflammatory, antioxidant, decongestant, and mucolytic properties. Therefore, this product may be fruitfully used in clinical practice.

  • Article
    S.E. Aragona, M. Zanoni, O. Sedigh, G. Savoca, G. Ciprandi, the Urosurvey Study Group
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 71-75. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.13
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    Urological disorders are very common and affect any age. The most common medical conditions include cystitis, urolithiasis, renal colic, and prostatitis. Broser® is a food supplement containing bromelain, escin,and selenium. Its efficacy has been positively tested in patients with otorhinolaryngological disorders.Therefore, the present clinical experience investigated the efficacy and safety of this product in patients with medical urological disorders and treated with standard therapy. The add-on Broser® course lasted 2 weeks. The oral nutraceutical was taken following the specific indications, such as two tablets/daily. Patients were visited at baseline (T0) and after the treatment (T1). Patients in Group A had to take Broser® one tablet b.i.d. per 20 days. Evaluation parameters were the following signs and symptoms: pain, functional powerlessness, fever, oedema, malaise, dysuria, and infection severity. Globally, 1,204 patients participated in this clinical experience. The median age was 52 years. The food supplement significantly reduced the symptom severity and the incidence of symptoms. In conclusion, the present clinical experience demonstrated that the add-on therapy with Broser® significantly reduced the severity and incidence of urological complaints. Therefore, this food supplement could be fruitfully used in clinical practice.

  • Article
    S.E. Aragona, M. Zanoni, O. Sedigh, G. Savoca, G. Ciprandi, the Urosurvey Study Group
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 77-81. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.14
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    Urological surgery is common at any age. The most common surgical procedures include urological surgery, endoscopy, genitals surgery, and cystoscopic procedures. Broser® is a food supplement containing bromelain, escin, and selenium. Its efficacy has been positively tested in patients with otorhinolaryngological disorders. Therefore, the present clinical experience investigated the efficacy and safety of this product in patients undergoing urological surgery and treated with standard therapy. The add-on Broser® course lasted 2 weeks. The oral nutraceutical was taken following the specific indications, such as two tablets/daily. Patients were visited at baseline (T0) and after the treatment (T1). Patients in Group A had to take Broser® one tablet b.i.d. per 20 days. Evaluation parameters were the following signs and symptoms: pain, functional powerlessness, fever, oedema, malaise, dysuria, and infection severity. Globally, 697 patients participated in this clinical experience. The median age was 58 years. The food supplement significantly reduced the symptom severity and the incidence of symptoms. In conclusion, the present clinical experience demonstrated that the add-on therapy with Broser® significantly reduced the severity and incidence of symptoms consequent to urological surgery. Therefore, this food supplement could be fruitfully used in clinical practice.

  • Article
    S.E. Aragona, G. Mereghetti, G. Ciprandi
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 83-86. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.15
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    Wound healing is a complex process whose understanding is constantly evolving. Until recently, the wound healing mechanism was imagined as a fibroproliferative response for producing a scaring, such as a repairing process. Recently, great attention has been addressed to biomaterials, stem cells, and bioengineered tissues. In this context, a new healthcare branch has developed: Regenerative Medicine. The healing process consists of three phases: the inflammatory reaction, cell proliferation (excessive or impaired), and extracellular matrix (ECM) remodelling. However, wound repair is usually characterised by the incomplete regeneration of the original tissue with hyperproduction of organised collagen, which can lead to new tissue production, with an 80% similarity to the original tissue. Also, impaired reparation leads to an abnormal fibroproliferative response, causing hypertrophic or keloid scars. Regenerative Medicine has promoted the study of tissue regeneration, mainly concerning the use of stem cells and electromagnetic applications. Consequently, the research developed in vitro and in vivo cellular models to investigate the tissue repair and regeneration process. Particular interest has been pointed to the role of humoral factors (cytokines and growth factors), genetic factors (genes expressed in the various phases of the process), and cellular factors. In addition,attention has been paid to fibroblasts, collagen, matrix metalloproteinases (MMPs), and tissue inhibitors of metalloproteinases (TIMPs), agents fundamental for the extracellular matrix (ECM) remodelling. Thus, the new perspective shifted from inflammation to regeneration. This idea concerns treating the patient with skin and mucosal wounds, using local anti-inflammatory compounds targeting endothelial cells, ECM, anti-inflammatory cytokines, and MMPs. The regeneration pathway starts from the platelet activation leading to the recruitment of neutrophils (natural “debrider”), the release of TGF-b1, PDGF, TNF-a, and IL-1, and regulation of adhesion molecules expression. Macrophages are further recruited to ensure sustained debridement, release proinflammatory cytokines, and amplify the fibroproliferative response in the context of chronic inflammation. Macrophages include the M1 subpopulation, which is devoted to eliminating invading microorganisms and promoting the early inflammatory response. The M2 subpopulation aims to eliminate damaged cells and tissues and promote neoangiogenesis and tissue remodelling. In addition, ECM may amplify some mechanisms of the healing process. In conclusion, Regeneration Medicine represents the keystone for a new holistic approach to wound management.

  • Article
    S.E. Aragona, G. Mereghetti, G. Ciprandi
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 87-95. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.16
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    Wound healing may require a long-standing period. As a result, patients, including their families and society, must sustain a relevant burden. Moreover, patients have to remain disabled also for a long time. Therefore, the healthcare service has to expend applicable costs. In the past, the Regeneration Medicine 3.0 represented the keystone for a holistic approach to wound management. However, there was also the need to consider the socio-economic impact on hospital costs and regional management spending review. Consequently, it is demanding to revise the care strategies for patients with skin wounds integrated into hospital-territory stewardship. In this regard, an innovative approach (Wound Regeneration 4.0) permitted to obtain exciting outcomes. Namely, an integrated protocol, combining anti-inflammatory, regenerative medicine, shortened the duration of wound healing, improved the quality of life of patients and family and significantly diminished the costs. In this context, the LumiHeal® gel associated with multi-LED light exerts a series of activities that actively promote wound healing. Moreover, LumiHeal® gel is active in all phases of wound healing and is effective on both chronic and acute wounds. The current outcomes suggest a multidisciplinary approach based on clinical, pharmacological, and economic issues that represent a point of departure for a new phase, such as the Wound Regeneration 4.0.

  • Article
    L. Drago, G. Meroni, D. Pistone, S.E. Aragona, F. Marampon, G. Rodà, G.V. Zuccotti, V. Tombolini, the Oncobiota Group
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 97-104. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.17
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    Objective: This study aimed to investigate the possible reduction of the side effects caused by cycles of anti-cancer therapies using a probiotic combination of Lacticaseibacillus rhamnosus LR04 (DSM 16605), Lactiplantibacillus pentosus (formerly Lactobacillus pentosus), LPS01 (DSM 21980), Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) LP01 (LMG P-21021), and Lactobacillus delbrueckii subsp. delbruekii LDD01 (DMS 22106).Methods: 180 patients were enrolled and grouped into four categories according to different cancers:breast (n = 38), lung (n=22), colon (n=55) and prostate (n=65). They received the probiotic combination with the first anti-cancer cycle (T0) for 30 days (T1) and reported the symptoms (nausea, vomit, etc.) using an absent-to-severe score. Results: Patients with prostate cancer registered a marked reduction in some symptoms after receiving the probiotic combination. Intestinal-related disorders showed a statistically significant decrease during the use of the probiotic (30 days). Nausea and vomit were reduced from 32.3% to 2.1% (p<0.0001), intestinal swelling from 53.8% to 21.6% (p<0.01), mucositis from 29% to 0 (p<0.001), diarrhea decreases from 38.4% to 8.1% (p<0.001), abdominal pain was reduced from 44.6% to 10.8% (p<0.001) and constipation from 40% to 13.5 % (p<0.05). Patients with colon cancer reported a decreased intestinal swelling over time (54.4% - 38.4%, p<0.05). No statistical differences were found in the two last groups (breast and colon cancer) for all the symptoms after introducing the probiotic. Conclusion: With a continuous focus on safety, a specific probiotic combination in contrasting the side effects of the anti-cancer therapies for the four different cancers here analysed should be considered. This pilot investigation was expected to provide only general indications that must be further validated with numerically larger studies and under more strict parameters.

  • Article
    M.E. Baldassarre, A. Di Maur, F. Cresi, S. Salvatore, S. Aragona, G. Ciprandi, the BB-12 Study Group
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 105-109. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.18
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    In infancy, cow’s milk allergy (CMA) is a common medical problem. However, there is no simple diagnostic tool, so a symptom-based score has been developed in clinical practice and parents. The Cow’s Milk-related Symptom Score (CoMiSS) includes the assessment of symptoms associated with intestinal,cutaneous, and respiratory complaints. The probiotic strain Bifidobacterium animalis subsp. lactis BB-12 (BB-12) is the world’s most documented probiotic Bifidobacterium. The present study aims to evaluate the effects exerted by a two-month BB-12 course on CoMiSS scores in infants with artificial feeding (partial or absolute). Infants were supplemented with six drops (1x109 CFU; ABINAT12®) daily (Group A; 499 subjects) or without any probiotic (Group B; 461 subjects) for two months. Paediatricians performed a baseline visit (T0) and after 30 (T1) and 60 (T2) days. In addition, the CoMiSS questionnaire was administered to the parents. BB-12 significantly improved near all items of CoMiSS both at T1 and T2. In conclusion, this experience demonstrated that symptoms potentially related to CMA represent a relevant medical problem in infants. In addition, a two-month BB-12 supplementation (ABINAT12®) significantly reduced the symptom severity of infants.

  • Article
    M.E. Baldassarre, A. Di Maur, F. Cresi, S. Salvatore, S. Aragona, G. Ciprandi, the BB-12 Study Group
    Journal of Biological Regulators and Homeostatic Agents. 2022, 36(2(S2)): 111-116. https://doi.org/10.23812/j.biol.regul.homeost.agents.202236.2S2.19
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    Infant regurgitation is the most common functional gastrointestinal disorder (FGID) worldwide and causes parental concern with relevant direct and indirect costs for families and the healthcare system. Bifidobacterium animalis subsp. lactis BB-12 (BB-12) is a well-known studied probiotic with evidence in managing another FGID, such as infantile colic. This real-life study evaluated the efficacy of BB-12 in decreasing functional regurgitation symptoms when supplemented in formula-fed infants (partial or absolute). In 17 outpatient services of the Italian National Pediatric Health Care System, formula-fed infants with persisting regurgitation symptoms were randomly (1:1) allocated to receive six drops (1x109 CFU of BB 12; ABINAT12®) daily (Group A) or any probiotic (Group B) for two months. Regurgitation symptoms were evaluated through the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R), performed at the baseline visit (T0) and after 30 (T1) and 60 (T2) days. A positive response was defined as a total score > 16. Nine hundred and sixty infants were randomly allocated to receive BB12 (Group A; 499 subjects) or any probiotic (Group B; 461 subjects). At baseline, 25.8% in Group A and 31.7% in Group B responded positively to the I-GERQ-R questionnaire. At T1, 16% in Group A and 45.8% in Group B (p<0.001) had a positive I-GERQ-R. At T2, 14.7% in Group A and 50.7% in Group B (p<0.001) had a positive I-GEQ-R. Consistently, the total scores significantly decreased in Group A. In conclusion, this real-life study demonstrated that a two-month BB-12 supplementation (ABINAT12®) significantly reduced regurgitation prevalence and severity in formula-fed infants.