Randomised controlled clinical trial of Lactobacillus sporogenes (Bacillus coagulans), used as probiotic in clinical practice, on acute watery diarrhoea in children

• Published in: Tropical medicine & international health 2011-05, Vol.16 (5), p.555-561
• Main Authors: Dutta, Phalguni, Mitra, Utpala, Dutta, Shanta, Rajendran, Krishnan, Saha, Tushar Kanti, Chatterjee, Mrinal Kanti
• Format: Article
• Language: English
• Subjects: acute diarrhoea; Acute Disease; Bacillus coagulans; Bacteria; Biological and medical sciences; children; Clinical outcomes; Clinical trials; Dehydration; Dehydration - etiology; diarrea aguda; Diarrhea; Diarrhea, Infantile - complications; Diarrhea, Infantile - microbiology; Diarrhea, Infantile - therapy; diarrhée aiguë; Dietary supplements; Diseases of the digestive system; Double-Blind Method; enfants; ensayo clínico aleatorizado; essai clinique randomisé; Gastroenterology. Liver. Pancreas. Abdomen; General aspects; Humans; Infant; Lactobacillus; Lactobacillus sporogenes; Male; Medical sciences; niños; Other diseases. Semiology; Pediatrics; Probiotics; Probiotics - therapeutic use; probiotiques; probióticos; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); randomised clinical trial; Rotavirus; Rotavirus Infections - therapy; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Treatment Outcome
• ISSN: 1360-2276; 1365-3156
• DOI: 10.1111/j.1365-3156.2011.02745.x

Summary Objective  To assess the clinical efficacy of Lactobacillus sporogenes (Bacillus coagulans), as probiotic preparation, against dehydrating diarrhoea in children. Methods  Double‐blind, randomised, placebo‐controlled, hospital‐based clinical trial with children aged 6–24 months who had diarrhoea with some dehydration. Children received tablets of L. sporogenes (B. coagulans) or placebo (control group) and oral rehydration salt solution for correction of initial dehydration as well as maintenance therapy. Duration, frequency, volume of diarrhoea and intake of ORS of two groups were compared as outcome variables. Results  One hundred and forty‐eight children participated, of whom 78 (Study group) received L. sporogenes (B. coagulans) and 70 received placebo (Control group). Differences in recovery rate (P = 0.2), duration (P = 0.5), frequency (P = 0.05), volume (P = 0.1) of diarrhoea, intake of ORS (P = 0.2) and other fluids (P = 0.1) were not significant between both groups. Neither did a subgroup analysis of children who had rotavirus as sole enteropathogens show any significant differences in duration (P = 0.5), frequency (P = 0.6), volume (P = 0.8) of diarrhoea, intake of ORS (P = 0.8) and other fluids (P = 0.8) among both groups. Conclusion  L. sporogenes (B. coagulans), as an adjunct to ORS, had no therapeutic impact on management of acute dehydrating diarrhoea of diverse etiology including rotavirus associated diarrhoea in children. Essai clinique randomisé contrôlé de l’utilisation de Lactobacillus sporogenes (Bacillus coagulans), comme probiotiques dans la pratique clinique, sur la diarrhée aiguë aqueuse chez les enfants Objectif:  Evaluer l’efficacité clinique de Lactobacillus sporogenes (coagulans Bacillus), comme préparation probiotique contre la diarrhée déshydratante chez les enfants. Méthodes:  Essai clinique en double aveugle, randomisé, contrôlé versus placebo, en milieu hospitalier sur des enfants de 6 à 24 mois ayant une diarrhée avec déshydratation. Les enfants ont reçu des comprimés de Lactobacillus sporogenes (Bacillus coagulans) ou un placebo (groupe témoin) et une solution de sels de réhydratation orale (SRO) pour la correction de la déshydratation initiale ainsi que comme traitement d’entretien. La durée, la fréquence, le volume de la diarrhée et la prise de SRO dans les deux groupes ont été comparés en tant que variables de résultat. Résultats:  148 enfants ont participé, dont 78 (groupe d’étude) ont reçu Lactobacillus sporog