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

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."

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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

"Pancitas felices y momentos felices con nuestro cliente @sanofi y Enterogermina! Gracias pana!" (@cahuenas)

Efficacy And Safety Of Enterogermina Vs Placebo In Adults With Small Intestinal Bacterial Overgrowth (SIBO) Efficacia e Sicurezza di Enterogermina verso placebo in adulti con aumentata crescita batterica a livello dell’intestino tenue (SIBO) (clinicaltrialsregister.eu) - P4; N=214; Terminated; Sponsor: SANOFI-AVENTIS GROUPE

Clinical • New P4 trial • Gastroenterology

Effect of Bacillus clausii Capsules in Reducing Adverse Effects Associated with Helicobacter pylori Eradication Therapy: A Randomized, Double-Blind, Controlled Trial. (PubMed, Infect Dis Ther) - "Compared with placebo, Enterogermina reduced the incidence of, and the number of days with, diarrhea in patients receiving H. pylori eradication therapy. Enterogermina® was well tolerated."

Adverse events • Clinical • Journal • Gastrointestinal Disorder • Infectious Disease

Composite genome sequence of Bacillus clausii, a probiotic commercially available as Enterogermina, and insights into its probiotic properties. (PubMed, BMC Microbiol) - "We identified various antibiotic resistance, bacteriocins, stress-related, and adhesion-related domains, and industrially-relevant pathways, in the genomes of these probiotic bacteria that are likely to help them survive in the harsh gastrointestinal tract, facilitating adhesion to host epithelial cells, persistence during antibiotic treatment and combating bacterial infections."

Journal • Gastrointestinal Disorder

Efficacy and Safety of Enterogermina vs Placebo in Combination with ORT and Zinc for 5 Days Treatment in Children with Acute Diarrhea in India (clinicaltrialsregister.eu) - P3; N=462; Sponsor: Sanofi Aventis Groupe

Clinical • Combination therapy • New P3 trial

"Doç. Dr. Şirin Güven; "Diyet microbiyotayı doğrudan etkileyen en önemli faktördür." @EnterogerminaTr @sanofi @dilarakocak @omurakkor #mikrobiyata #mikrobiyom #bagirsak #diyetisyendunyasi #enterogermina #diyet" (@dytdunyasi)

Synthesis of silver nanoparticles by Bacillus clausii and computational profiling of nitrate reductase enzyme involved in production. (PubMed, J Genet Eng Biotechnol) - "...cultured from Enterogermina is explored...Structure validation was done by GROMACS and RMSD, RMSF, temperature variation plot were also plotted. Interactions graphs between nitrate reductase and ligand silver nitrate was done through molecular docking using Hex."

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