Trial reportPaediatric drugs2023
Efficacy and Safety of the Adjuvant Use of Probiotic Bacillus clausii Strains in Pediatric Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study.
Trial report in Paediatric drugs, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 4 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Probiotics in pediatric functional abdominal pain disorders: a systematic review and meta-analysis.European journal of pediatrics · 2026Pooled it
- Comparative efficacy of probiotic, prebiotic, and synbiotic interventions in children with functional abdominal pain disorders: a systematic review and network meta-analysis.Frontiers in nutrition · 2026Pooled it
- European Consensus on Functional Bloating and Abdominal Distension-An ESNM/UEG Recommendations for Clinical Management.United European gastroenterology journal · 2025Guideline
- ESPGHAN/NASPGHAN guidelines for treatment of irritable bowel syndrome and functional abdominal pain-not otherwise specified in children aged 4-18 years.Journal of pediatric gastroenterology and nutrition · 2025Guideline
- Saccharomyces boulardii's impact on pediatric diarrhea-predominant irritable bowel syndrome: animal model findings.Pediatric research · 2026Trial
- Review
- Maternal Bacillus probiotic regulates offspring growth and immunity via spleen IGF-1/mTOR and FOXO1/IL-10 pathways.Scientific reports · 2026Article
- Efficacy and Safety of Probiotics in Children with Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis.Microorganisms · 2025Review
- Article
- Serum level of TNF-a, IL-1 and IL-6 and serum biomarkers after nutritional change in patients' ventilator-associated pneumonia.Journal of medical biochemistry · 2025Article
- Fructose-Induced Impairment of Liver and Skeletal Muscle Metabolism Is Prevented by Administration of Shouchella clausii Spores by Preserving Mitochondrial Function and Insulin Sensitivity.Molecular nutrition & food research · 2025Article
- Dietary and complementary oral supplements for the management of chronic diseases in children: a systematic review.Frontiers in pediatrics · 2025Review
- Randomized Clinical Trials Demonstrate the Safety Assessment ofMicroorganisms · 2024Article
- Effects ofNutrients · 2024Article
- Italian guidelines for the management of irritable bowel syndrome in children and adolescents : Joint Consensus from the Italian Societies of: Gastroenterology, Hepatology and Pediatric Nutrition (SIGENP), Pediatrics (SIP), Gastroenterology and Endoscopy (SIGE) and Neurogastroenterology and Motility (SINGEM).Italian journal of pediatrics · 2024Review
- Unraveling the complexity of Disorders of the Gut-Brain Interaction: the gut microbiota connection in children.Frontiers in pediatrics · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesCurrent irritable bowel syndrome (IBS) treatments have limited efficacy and probiotics like Bacillus clausii (B. clausii) were found to be effective in the management of several gastrointestinal disorders. This phase III trial assessed the efficacy and safety of adding B. clausii (four strains: O/C, N/R, SIN, T), versus placebo, to conventional treatment of pediatric IBS in Mexico.
methodsPatients aged 6-17 years 11 months with IBS (Rome IV) for at least 2 months were randomized to receive either B. clausii (oral suspension, total dose 4 billion spores/day) or placebo once daily for 8 weeks. All patients also received conventional treatment. The primary endpoint was the difference in the proportion of patients with clinical improvements at Week 8 (Global Assessment Questions [GAQ]). Secondary endpoints included responders by Subject's Global Assessment of Relief for Children with IBS (SGARC); number/consistency of stools; abdominal distention/bloating; abdominal pain/intensity; and IBS behavior.
results73.6% (95% confidence interval [CI] 67.3-80.0; B. clausii n = 129) and 78.5% (95% CI 72.5-84.4; placebo n = 130) of patients had symptom improvement (p = 0.8182). For Week 8 SGARC, 19.2% (B. clausii) and 20.9% (placebo) reported complete symptom relief. Stool evaluations, bloating, abdominal pain/intensity, and IBS behavior were similar between groups. Both treatments were well tolerated.
conclusionNo significant differences in efficacy between B. clausii and placebo were demonstrated in addition to conventional treatment. The sample size calculation was based on an expected placebo/conventional treatment response of 30-40%. However, the actual treatment response observed was 80% and, thus, a study with larger population would be warranted. In addition, this study was conducted during the COVID-19 pandemic, when such controlled social conditions may have resulted in better diet, greater family stability, less psychological stress, and lower risk of infections exacerbating IBS, thereby improving symptoms in both groups. EUDRACT NUMBER: 2018-004519-31.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.