Efficacy of Bifidobacterium breve fermented milk in maintaining remission of ulcerative colitis
Open accessAbstract
BACKGROUND: Fermented milk products containing Bifidobacterium breve strain Yakult (BFM) may improve clinical status in ulcerative colitis (UC) patients. AIMS: To assess efficacy of BFM in maintaining remission in Japanese patients with quiescent UC. METHODS: This double-blind study (B-FLORA) enrolled 195 patients with quiescent UC, randomized to receive one pack of BFM fermented milk per day [Bifidobacterium breve strain Yakult (10 billion bacteria) and Lactobacillus acidophilus (1 billion bacteria)] (n = 98) or matching placebo (n = 97) for 48 weeks. The primary efficacy endpoint was relapse-free survival (relapse: rectal bleeding score ≥ 2 on Sutherland disease activity index scale for 3 consecutive days and/or initiation of remission induction therapy for worsening of UC). RESULTS: An interim analysis was conducted after inclusion and follow-up of one-third of patients for the first phase of the study (n = 195). Relapse-free survival was not significantly different between the BFM and placebo groups (P = 0.643; hazard ratio 1.16; 95% CI 0.63-2.14, log-rank test), nor was the incidence of relapse. Therefore, the study was discontinued for lack of efficacy. An exploratory analysis of fecal samples from a subgroup of patients revealed no effects of either study beverage on intestinal microbiota, but there was a significant decrease in Bifidobacterium species before relapse, regardless of treatment group. Three mild adverse events occurred for which a causal relationship with the study beverage could not be ruled out (placebo: abdominal bloating and stress in one patient; BFM: body odor in one patient). CONCLUSIONS: BFM had no effect on time to relapse in UC patients compared with placebo. STUDY REGISTRATION: UMIN000007593.
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The B. breve strain in Yakult did not delay relapse time compared to a matched placebo in patients with inactive UC.
“However, a recent study found that the B. breve strain in Yakult did not delay relapse time, compared to a matched placebo in patients with inactive UC.”
From Stress triggers flare of inflammatory bowel disease in children and adults (2019) · cites this paper as [140]
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- Authors
- Matsuoka, K., Uemura, Y., Kanai, T., Kunisaki, R., Suzuki, Y., Yokoyama, K., Yoshimura, N., & Hibi, T.
- Affiliations
- Tokyo Medical and Dental University (JP)
- University of Tokyo Hospital (JP)
- Yokohama City University Medical Center (JP)
- Toho University (JP)
- Kitasato University (JP)
- Tokyo Yamate Medical Center (JP)
- Venue
- Digestive Diseases and Sciences
- Published
- 2018-02-15
- Volume
- 63
- Issue
- 7
- Pages
- 1910-1919
- ISSN
- 0163-2116 (ISSN-L)
- 1573-2568
- PMC
- PMC6015104
- OpenAlex
- W2789624862
- Cited by
- 128
- References
- 21
- Citations by year
- 2026: 5 · 2025: 11 · 2024: 27 · 2023: 19 · 2022: 23 · 2021: 16 · 2020: 11 · 2019: 14 · 2018: 1
- FWCI
- 6.43
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Digestive Diseases and Sciences (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Funders
- The research funding was provided to the Comprehensive Support Project for Clinical Research of Lifestyle-Related Disease (CSP-LD) of the PHRF by Yakult Honsha Co., Ltd.
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- ulcerative colitis, Bifidobacterium breve, Yakult, fermented milk, probiotics, remission maintenance, relapse, Lactobacillus acidophilus, gut microbiota, fecal microbiota
- MeSH terms
- Gastrointestinal Microbiome, Bifidobacterium breve, Adult, Aged, Colitis, Ulcerative, Double-Blind Method, Female, Humans, Intestines, Japan, Lactobacillus acidophilus, Male, Middle Aged, Recurrence, Remission Induction, Time Factors, Treatment Outcome, Disease-Free Survival, Cultured Milk Products, Young Adult
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