Bacillus clausii UBBC-07 reduces severity of diarrhoea in children under 5 years of age: a double blind placebo controlled study
Abstract
Acute diarrhoea is one of the leading causes of mortality in infants and young children. Evidence suggests that probiotics can reduce diarrhoea duration. As the effects of probiotics are strain specific, the effect of Bacillus clausii UBBC-07, a safe probiotic strain in the treatment of acute diarrhoea in children was studied. The double blind, randomised, placebo-controlled, parallel group multicentric study was conducted at two outpatient facility sites in Lucknow, India. Children aged six months to five years suffering from acute diarrhoea, were randomly assigned to receive either probiotic ( B. clausii UBBC-07) spore suspension or placebo suspension twice daily apart from oral rehydration solution (ORS). The duration of treatment was for five days with a follow -up until the 10 th day. Outcomes evaluated were duration and frequency of diarrhoea, consistency of stool, fever and vomiting. The duration of diarrhoea was significantly shorter ( P <0.05) in patients who received B. clausii suspension (75.66±13.23 h) than in placebo treated group (81.6±15.43 h). The average daily number of stools (frequency) was 8.67±3.42 at baseline in treatment group receiving B. clausii and 8.53±3.19 in placebo group. By day 4, there was a significant reduction ( P <0.01) in frequency of stools in probiotic treated group (3.46±0.66) as compared to placebo group (4.57±1.59). Improvement in stool consistency was also observed in the probiotic treated group as compared to the placebo group. There was no effect on vomiting and duration of fever. B. clausii UBBC-07 significantly decreased the duration and frequency of diarrhoea as compared to placebo indicating effectiveness of strain in the treatment of acute diarrhoea in children and could be a safe alternative to antibiotics.
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B. clausii UBBC-07 (Tufpro) decreased diarrhea duration in Indian children (75.66 vs. 81.6 hours, p < 0.05).
“Other clinically supported strains include B. clausii UBBC-07 (Tufpro), which decreased diarrhea duration in Indian children (75.66 vs. 81.6 hours, p < 0.05),46”
From Safety and efficacy concerns in Indian probiotics: Insights from whole-genome sequencing and <i>in vitro</i> assessment (2026) · cites this paper as [46]
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“…supported strains include B. clausii UBBC-07 (Tufpro), which decreased diarrhea duration in Indian children (75.66 vs. 81.6 hours, p 0.05), 46 and L. rhamnosus ATCC 53103 (Sporit GG, Sporlac GG), which significantly reduced infantile colic (104 vs. 242 minutes, p 0.001) and increased…”
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- Authors
- Sudha, M. R., Jayanthi, N., Pandey, D. C., & Verma, A. K.
- Affiliations
- Centre for Research & Development, Unique Biotech Ltd., Plot No. 2, Phase-II, Alexandria Knowledge Park, Hyderabad, Telangana 500078, India.
- M.V. Hospital and Research Centre (IN)
- K.R.M. hospital and Research Centre, Department of Pediatrics, Room No 01 3/92-93,Vijayant Khand Lucknow, Uttar Pradesh, India.
- Venue
- Beneficial Microbes
- Publisher
- Walter de Gruyter GmbH
- Published
- 2019-03-13
- Volume
- 10
- Issue
- 2
- Pages
- 149-154
- ISSN
- 1876-2883 (ISSN-L)
- 1876-2891
- OpenAlex
- W2908780846
- Cited by
- 53
- References
- 27
- Citations by year
- 2026: 3 · 2025: 8 · 2024: 4 · 2023: 8 · 2022: 16 · 2021: 5 · 2020: 5 · 2019: 4
- FWCI
- 5.79
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Beneficial Microbes (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Nursing › Nutrition and Dietetics › Infant Nutrition and Health
- Health Sciences › Medicine › Infectious Diseases › Viral gastroenteritis research and epidemiology
- Keywords
- probiotics, acute diarrhea, childhood diarrhea, diarrhea duration, stool consistency, oral rehydration solution, infants and young children, antibiotic alternatives
- MeSH terms
- Bacillus clausii, Child, Preschool, Diarrhea, Double-Blind Method, Feces, Female, Humans, India, Infant, Male, Placebos, Time Factors, Treatment Outcome, Probiotics, Chemical Phenomena
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