ArticleGut pathogens2025
The effects of probiotic treatment with Bifidobacterium breve, Bif195 for small intestinal Crohn's disease and the gut microbiome: results from a randomised, double-blind, placebo-controlled trial.
Article in Gut pathogens, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04842149 (The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease), which is not on this map. Cited by 7 papers.
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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.
The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease: a Double-blind, Randomized, Placebo-controlled Study
Who cites it
7 citing papers in PubMed.
- Eight weeks of treatment with probioticFrontiers in nutrition · 2025Trial
- Intervention WithFood science & nutrition · 2026Article
- Gut microbiome features associated with Bifidobacterium colonization predict personalized probiotic persistence patterns.Nature communications · 2026Article
- From One-Size-Fits-All to Precision Medicine: The Promise of Personalized Probiotics.Probiotics and antimicrobial proteins · 2026Review
- A Developmental Perspective on the Intestinal Microbiota in Crohn's Disease.International journal of molecular sciences · 2026Review
- Current and emerging approaches to manage chronic inflammatory gut disorders.Frontiers in cellular and infection microbiology · 2026Review
- First metagenomic analysis of age-associated changes in the gut microbiome among healthy Saudi adults: SAMS pilot study.Frontiers in aging · 2026Article
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
backgroundThe aetiology of Crohn's disease, a chronic inflammatory bowel disease, is multifactorial and not completely understood. However, the association with gut dysbiosis is well-established, and manipulation of the gut microbiota has gained interest as a treatment strategy. This study aimed to investigate the effects of the probiotic strain Bifidobacterium breve, Bif195™ (Bif195) on intestinal inflammation, symptoms, and the gut microbiome composition in patients with small intestinal Crohn's disease.
methodsThis was a randomised, double-blind, placebo-controlled trial. Thirty-three patients with small intestinal Crohn's disease were assigned to eight weeks of treatment with Bif195 or placebo (1:1). The primary outcome was changes in bowel wall thickness measured by intestinal ultrasonography. Other outcomes were changes in symptom severity, quality of life, faecal calprotectin, fatigue, and specific inflammatory parameters on ultrasonography. Changes in the microbiome composition were also examined.
resultsBif195 did not affect the bowel wall thickness in the small intestine compared to placebo. Nor did we observe effects on secondary or clinical explorative outcomes. Analysis of the gut microbiome showed that the relative abundance of B. breve rose during the intervention in the Bif195 group, but the result was statistically non-significant. Surprisingly, we observed a clustering of baseline microbiome data into two groups that differed in several aspects including a statistically significant difference in the incidence of previous bowel resections among the participants. Furthermore, changes in symptom scores after eight weeks of intervention were significantly different across the two microbiome groups, with an interaction effect of p = 0.04.
conclusionsEight weeks of treatment with Bif195 did not affect clinical outcomes for Crohn's disease. However, variations in baseline microbiome data influenced the results. This underscores the importance of assessing baseline microbiome data in intervention studies in Crohn's disease. CLINICALTRIALS: gov NCT04842149.
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