The Efficacy and Safety of a Bacillus Probiotic Combination for the Treatment of Acute Diarrhea in Children: A Double-blind, Randomized, Placebo-controlled Multicentric Study
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prevention and treatment of gastroenteritis in several randomized controlled trials and meta-analyses.7 There have been reports that regular consumption of products containing probiotics will strengthen the body's immune system, produce an anti-allergy effect, reduces the risk for certain cancers, IntroductIonDiarrhea is defined as the passage of three or more loose or liquid stools/day (or more frequent passage than is normal for the individual).1 There is either an increase in the frequency or a decrease in the consistency of the bowel movements.Diarrhea affects people of all ages.Diarrhea is considered as a sign of an infection in the intestines, which is caused by bacteria, viruses, and parasites.In developing countries, diarrhea is considered as the second leading cause of mortality and morbidity in children.In a global scenario, it is estimated that in children below 5 years of age, there are 2.5 billion episodes of diarrhea and almost 1.5 million deaths annually due to diarrhea.2 Viruses, bacteria, and parasites are the most common infectious causes of acute diarrhea.Medication adverse effects, acute abdominal processes, gastroenterological disease, and endocrine disease are all examples of noninfectious causes.3 Diarrhea is one of the most commonly reported adverse reactions to antibacterial medications.4 AAD is observed in almost 5-30% of patients undergoing antibiotic therapy in the initial phase or even up to 2 months after the treatment is over.In pediatric populations, probiotics have been thoroughly researched in the past and are still continued to date for the prevention and, to a greater extent, in the treatment of several diarrheal diseases.6 Probiotics are known to be effective in the
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B. subtilis HU58 in Darolac aided antibiotic-associated diarrhea recovery.
“B. subtilis HU58 in Darolac also aided AAD recovery.48”
From Safety and efficacy concerns in Indian probiotics: Insights from whole-genome sequencing and <i>in vitro</i> assessment (2026) · cites this paper as [48]
The Discussion and Conclusion (pages unavailable) report benefits for antibiotic-associated diarrhea in children, but the tested probiotic combined B. subtilis HU58 with B. coagulans SC208. The Interventions section describes that combination as a syrup; our copy does not identify it as Darolac or establish that HU58 alone aided recovery. (LLM, conf=0.86)
Experimental — accuracy not yet measuredWhole-genome sequencing has identified antimicrobial resistance determinants with predicted mobilization potential, including tet(L), catA10, and ant(4′)-Ib, in some Lactobacillus sporogenes (Bacillus coagulans) formulations.
“For example, whole-genome sequencing has identified antimicrobial resistance determinants with predicted mobilization potential, including tet(L), catA10, and ant(4′)-Ib, in some Lactobacillus sporogenes (Bacillus coagulans) formulations, raising concerns regarding their quality and reliability.48,49”
From Safety and efficacy concerns in Indian probiotics: Insights from whole-genome sequencing and <i>in vitro</i> assessment (2026) · cites this paper as [48]
The Randomization passage describes a trial of B. coagulans SC208 and B. subtilis HU58, while the Conclusion discusses their probiotic properties; neither reports whole-genome sequencing of formulations. Searches for tet(L), catA10, ant(4′)-Ib, and mobile resistance determinants found no passage addressing the claimed finding. The indexed passages provide no page numbers. (LLM, conf=0.75)
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Cites
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Flagged first, then by citations
Research works printed but not linked: 3
- Wang CR, Jin J. Effect of Medilac-S on diarrhea caused by an imbalance of intestinal flora. J Med Forum 2006;27:74-75.
- Dound Y, Jadhav SS, Devale M, et al. The effect of probiotic Bacillus subtilis HU58 on immune function in healthy human. The Indian Practitioner 2017;70:15-20.
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Cited by
Sorted by citations
Madhumathi, I., Ramesh, V., Rathakrishnan, B., Abirami, B., Gunasekaran, K., Kumar, T. S., Jeyasankar, P., Raja, G., Selvam, K., Rajendran, S., et al. (2026) · Gut microbes reports · doi:10.1080/29933935.2026.2668863
“48,49”
- Authors
- Dhongade, A. R., Joshi, S. S., Kulkarni, S. V., Jadhav, S. S., Nargundkar, N., Deshmukh, D., & Mehta, A. D.
- Affiliations
- Jawahar Medical Foundation's Annasaheb Chudaman Patil Memorial Medical College & Hospital (IN)
- Venue
- Pediatric Infectious Disease
- Publisher
- Jaypee Brothers Medical Publishing
- Published
- 2022-08-31
- Volume
- 4
- Issue
- 3
- Pages
- 86-91
- ISSN
- 2582-4988 (ISSN-L)
- OpenAlex
- W4294031763
- Cited by
- 5
- References
- 24
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 1
- FWCI
- 0.40
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- cc-by-nc
- Locations
- Pediatric Infectious Disease (publishedVersion, cc-by-nc)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Health Sciences › Nursing › Nutrition and Dietetics › Infant Nutrition and Health
- Keywords
- probiotics, Bacillus, acute diarrhea, children, antibiotic-associated diarrhea, gastroenteritis
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