Enterogermina (bacillus clausii multi-antibioresistant spores) / Sanofi - LARVOL DELTA

Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children (clinicaltrials.gov) - P=N/A | N=138 | Not yet recruiting | Sponsor: Children Hospital and Institute of Child Health, Lahore

New trial

Bacillus Subtilis THC1I Restores Intestinal Barrier Integrity and Gut Microbiota Balance in a Mouse Model of Antibiotic-Associated Diarrhea. (PubMed, Curr Microbiol) - "AAD was induced with gentamycin sulfate and cefradine for five consecutive days. B. subtilis THC1I demonstrates restorative effects on intestinal barrier damage and gut microbiota dysbiosis in AAD mice, supporting its potential as a therapeutic candidate for clinical application."

Journal • Preclinical • Hematological Disorders • Inflammation • IL1B • TNFA

Accidental Intravenous Administration of Oral Bacillus clausii Probiotic (Enterogermina) in a Toddler: A Case Report. (PubMed, Cureus) - "He was immediately transferred to the pediatric intensive care unit, where empirical intravenous piperacillin-tazobactam and teicoplanin were started. Prompt recognition, intensive monitoring, and broad-spectrum antibiotics prevented serious complications. It highlights the urgent need for strict medication safety protocols, staff training, and clearer product labeling to avoid such preventable errors in pediatric practice."

Journal • Critical care • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Pediatrics • Rotavirus Infections • Systemic Inflammatory Response Syndrome

Probiotic Effect on Quality of Life, Bowel Habits and Weight Loss after Different Types of Bariatric Surgeries, a Randomized Controlled Trial. (PubMed, Obes Surg) - "The probiotic use post-bariatric surgery offers measurable benefits in QOL, weight loss, and gastrointestinal inflammation, regardless of the surgical type. Although procedures like RYGB and OAGB yield superior weight loss, they may induce higher gut inflammation. Meanwhile, sleeve gastrectomy appears to be the most gut-friendly in terms of inflammatory markers and bowel consistency."

HEOR • Journal • Gastrointestinal Disorder • Genetic Disorders • Inflammation • Inflammatory Bowel Disease • Obesity

Quantitative Evaluation of the Inhibitory Effects of Commercially Available Probiotics on Dual-Species Biofilms in Root Canals: A qPCR-Based Short-Term In Vitro Study. (PubMed, Antibiotics (Basel)) - "Clinical Relevance: This in vitro study provides experimental insight into the limitations of directly applying commercially available gastrointestinal probiotic formulations within the root canal system. The findings highlight the importance of developing root canal-specific probiotic strains and delivery strategies tailored to the unique ecological conditions of the intracanal environment, thereby informing future translational and experimental research in biological endodontics."

Journal • Preclinical • KEAP1

Evaluating the Compositional Quality of Probiotics Containing Bacillus clausii in India. (PubMed, Adv Ther) - "The study revealed significant differences in the quality of probiotics on the Indian market, highlighting concerns about their potency and safety. Stringent quality control is necessary to ensure consumer safety and help healthcare professionals make informed decisions."

Journal

Single Strain vs Multiple Strain Probiotics: The Clinician's Choice. (PubMed, Cureus) - "On the other hand, the most commonly prescribed multi-strain probiotics prescriptions included a combination of Streptococcus faecalis, Clostridium butyricum, Bacillus mesentericus, and Lactobacillus sporogenes (37.85% [1,656/4,375]). Conclusion The study showed a greater preference pattern for single-strain probiotics, particularly Enterogermina among pediatricians."

Journal • Pediatrics

Can probiotics be protective and growth-promoting to coffee plants? (PubMed, World J Microbiol Biotechnol) - "These findings suggest that Colostrum® BS Powder and Colostrum® BIO 21 MIX Powder, that are safe for the environment and have their mass production well developed, could offer a promising, eco-friendly approach to enhancing plant health and coffee seedling growth. After further studies in field conditions they can become important tools to improve sustainable coffee production."

Journal

A Comprehensive Review and Meta-analysis on the Treatment of Acute Gastroenteritis in Children with a Bacillus clausii Preparation (Enterogermina®). (PubMed, Adv Ther) - "We conclude that the B. clausii preparation analyzed here is an effective and well-tolerated treatment of acute gastroenteritis in children. However, more high-quality randomized controlled trials are needed, particularly in comparison to other probiotics."

Journal • Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder

A Prospective Real-World Study of Bacillus clausii Evaluating Use, Treatment Habits and Patient Satisfaction in Italian Community Pharmacies: The PEGASO Study. (PubMed, Drugs Real World Outcomes) - "This is the first pharmacy-based study in Italy that evaluated the real-world usage of an OTC probiotic containing B. clausii among self-medicating adults. Diarrhoea was the most common reason for use, with high-level of perceived effectiveness and patient satisfaction with B. clausii."

Journal • Real-world • Real-world evidence • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Bacillus Clausii in Liver Transplantation (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Ain Shams University | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2023 ➔ Aug 2023 | Trial primary completion date: Mar 2023 ➔ May 2023

Enrollment closed • Trial completion date • Trial primary completion date • Hepatology • Infectious Disease • Transplantation

"@InterpublicIPG, @Mccann_mw, @Acxiom, @sanofi, @fer_machado123, @femalequotient, @McCann_Spain, @EnterogerminaBR" (,@Global_MRM)

"Con su nueva campaña regional "Cuidar para Cuidarte", @sanofi busca disminuir la muerte infantil por diarrea aguda y destaca la importancia de consumir productos como Enterogermina. https://t.co/xumXUjopWY" (,@SpeysideGroupMX)

"@Pharmaton_TR @EnterogerminaTr @sanofi Sizce bu diger panolar reklam almayı başaramadığı için mi boş?! #deprem" (,@Alitaskin2427)

Investigation of Enterogermina's Protective and Restorative Mechanisms on the Gut Microbiota with PPI, Using SHIME Technology. (PubMed, Nutrients) - "Probiotic use countered some of the effects of PPI use: Streptococcus bovis levels increased in the control arm but reduced following probiotic treatment. These results show that probiotic treatment with B. clausii may have beneficial effects on the gut microbiota following PPI treatment."

Journal

Bacillus Clausii in Liver Transplantation (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Ain Shams University | Trial completion date: Dec 2022 ➔ Apr 2023 | Trial primary completion date: Oct 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Hepatology • Infectious Disease • Transplantation

Quantitative and qualitative characterization of commercially available oral suspension of probiotic products containing Bacillus Clausii spores. (PubMed, BMC Microbiol) - "The 16S rRNA gene-sequencing data detected genera of Bacillus and Bacillus clausii strain in the BACIPRO®, ENTEROGERMINA®, PROALANA-B®, BENEGUT®, and TUFPRO® products; however, Ralstonia mannitolilytica and Paenibacillus dendritiformis species were identified in β-LOCK® and PROCILLUS®, respectively. As correct label information was observed only in BACIPRO®, ENTEROGERMINA®, and TUFPRO® products, it is proposed that a more stringent quality check would minimize the possibility of mismatch concerning the label information."

Journal • Hematological Disorders

Evaluating the Effect of Supplementation with Bacillus clausii on Therapeutic Outcomes in Atopic Eczema-Results of an Observer-Blinded Parallel-Group Randomized Controlled Study. (PubMed, Indian J Dermatol) - "Lack of double-blinding, lack of the use of placebo and a short follow-up period were the limitations of the present study. Administration of the probiotic Bacillus clausii in addition to conventional treatment does not offer any additional benefit in inducing remission or prevention relapse in AD."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL17A

In vitro and in vivo evaluation of Bacillus clausii against Schistosoma mansoni. (PubMed, Acta Trop) - "B. clausii CFS, in vitro, does not showed action against S. mansoni and that treatment with B. clausii spores modulates favorably the parasitological parameters in the experimental infection of S. mansoni."

Journal • Preclinical • Infectious Disease

Efficacy and safety of Bacillus clausii (O/C, N/R, SIN, T) probiotic combined with oral rehydration therapy (ORT) and zinc in acute diarrhea in children: a randomized, double-blind, placebo-controlled study in India. (PubMed, Trop Dis Travel Med Vaccines) - P3 | "No significant difference in efficacy between B. clausii and placebo was demonstrated. Sample size may have been inadequate to allow detection of a between-group difference in efficacy, given the mild/moderate severity (only ~ 20% of patients had nausea/vomiting or abdominal pains) and short duration of disease among subjects, the relatively late start of treatment (most were already on Day 2 of their disease episode when study treatment started) and the effectiveness of the standard of care with ORT and zinc in both treatment groups."

Clinical • Journal • Immunology • Pain

"El nene con diarrea el médico indico enterogermina. $1800 mangos😱😱 Claro industria italiana, menos de 10€ Gracias @alferdez por fundirnos día a día #albertotoqueton #SeVan @sanofi #enterogermina" (,@GorilaconLMC)

Bacillus Clausii in Liver Transplantation (clinicaltrials.gov) - P2; N=70; Recruiting; Sponsor: Ain Shams University

New P2 trial • Hepatology • Infectious Disease • Transplantation

[VIRTUAL] SIGNIFICANCE OF BLOOD CULTURE IN DIAGNOSIS OF SEPTICEMIA WITH AN UNUSUAL PATHOGEN IN A PEDIATRIC CARDIAC PATIENT. (ESPID 2021) - "This was sensitive to Penicillin and Vancomycin by the E test(Biomerieux France) according to the CLSI M45 guidelines. Usually Bacillus species isolated from a single blood culture are often dismissed as contaminants. It would be advisable to send multiple blood cultures in septicaemic patients before dismissing the isolates as contaminants."

Cardiovascular • Cognitive Disorders • Heart Failure • Infectious Disease • Pediatrics • Septic Shock

"Thankyou @sanofi for Enterogermina ❤️" (,@HeyyMahira)

Kinetics of Intestinal Presence of Spores Following Oral Administration of Bacillus clausii Formulations: Three Single-Centre, Crossover, Randomised, Open-Label Studies. (PubMed, Eur J Drug Metab Pharmacokinet) - "These results show different formulations of Enterogermina had similar kinetic profiles within each study; however, they also showed that probiotics could be associated with high variability. The European Medicines Agency guidelines are the current bioequivalence reference, although only the T parameter is used for high variability drugs. Due to the specific kinetics of probiotics, new parameters of bioequivalence could be necessary, considering, for example, variability via a parameter such as AUC."

Clinical • Journal • Gastroenterology • Gastrointestinal Disorder