Trial reportThe American journal of gastroenterology2017
Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating.
Trial report in The American journal of gastroenterology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06252558 (Do Symbiotics Provide Helpful Benefits in Gastrointestinal Related Issues in Weight Loss Surgery Patients?), which is not on this map. Cited by 15 papers, 1 of them a synthesis 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.
Do Symbiotics Provide Helpful Benefits in Gastrointestinal Related Issues in Weight Loss Surgery Patients?
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.
- European Consensus on Functional Bloating and Abdominal Distension-An ESNM/UEG Recommendations for Clinical Management.United European gastroenterology journal · 2025Guideline
- An eight-week placebo-controlled RCT on the efficacy of a probiotic nutritional intervention for subclinical gastrointestinal symptoms in students.Scientific reports · 2026Trial
- A Randomized, Placebo-Controlled Trial Evaluating Multi-Species Synbiotic Supplementation for Bloating, Gas, and Abdominal Discomfort.Nutrients · 2026Trial
- Clinical Guidance and Practical Recommendations for Probiotic Use in Patients With Irritable Bowel Syndrome, Functional Constipation, andJournal of neurogastroenterology and motility · 2026Review
- Clinical guidance and practical recommendations for probiotic use in patients with irritable bowel syndrome, functional constipation, and Clostridioides difficile infection considering sex-based differences: a Korean translation.Ewha medical journal · 2026Article
- The gut virome in association with the bacteriome in gastrointestinal diseases and beyond: roles, mechanisms, and clinical applications.Precision clinical medicine · 2025Review
- Assessing the Impact of Probiotic Consumption on Gastrointestinal Health in Saudi Arabia: a Cross-Sectional Study.Materia socio-medica · 2025Article
- Functional Abdominal Bloating and Gut Microbiota: An Update.Microorganisms · 2024Review
- Insights Into the Role of the Microbiome in Irritable Bowel Syndrome.Gastroenterology & hepatology · 2024Article
- Article
- Probiotic Supplements: Their Strategies in the Therapeutic and Prophylactic of Human Life-Threatening Diseases.International journal of molecular sciences · 2021Review
- The effect of a short-term physical activity after meals on gastrointestinal symptoms in individuals with functional abdominal bloating: a randomized clinical trial.Gastroenterology and hepatology from bed to bench · 2021Article
- Consumption of a Fermented Milk Product ContainingNutrients · 2019Article
- Editorial: Clinical Implications of Diagnosing Irritable Bowel Syndrome: Do All Roads Need to Lead to Rome?The American journal of gastroenterology · 2017Article
- Agents that act luminally to treat diarrhoea and constipation.Nature reviews. Gastroenterology & hepatology · 2012Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesBifidobacterium infantis 35624 is a probiotic that is used often in patients with irritable bowel syndrome (IBS). Non-patients with bowel symptoms may differ from patients with IBS in the impact of their bowel symptoms on illness severity, healthcare and treatment seeking behavior. The aim of this study is to assess the efficacy of B. infantis 35624 (10
methodsA double-blind, randomized, placebo-controlled, parallel study with a 2-week placebo run-in phase followed by a 4-week intervention phase was conducted at ten clinical centers (USA). Subjects were recruited from the general population by advertisement. The study randomized 302 subjects who experienced abdominal discomfort and bloating ≥2-times per week for at least three months but have not seen a physician or received prescribed medication for their symptoms in the past 12 months. Subjects were assessed for pre- to post-intervention changes in symptom severity (on a 6-point Likert scale; 0=none, 5=very severe) and frequency (symptoms-free days).
resultsA total of 275 subjects (mean age 42 years, 79% female, 74% Caucasian) provided evaluable data. Overall mean severity scores at baseline were 2.4 for abdominal discomfort and 2.5 for bloating with no significant differences between the placebo and probiotic groups. Both groups showed significant (P<0.05) improvement in abdominal discomfort and bloating scores over the 4-week intervention period. Mean severity symptom scores at the end of intervention showed no significant differences between the probiotic and the placebo groups in either abdominal discomfort or bloating (P>0.3). The frequency of abdominal bloating-free days was greater in the B. infantis 35624 group compared to the placebo group (P<0.05). Both regimens were well tolerated.
conclusionsUnlike previous clinical studies in patients with IBS, B. infantis 35624 did not show a significant improvement in the mean severity of symptoms of abdominal discomfort and bloating in a non-patient population. This may be explained by the high placebo effect and the lower impact of functional bowel symptoms in the non-patient population.
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