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Efficacy of Bifidobacterium breve Fermented Milk in Maintaining Remission of Ulcerative Colitis

  • 2018-02-15
  • Digestive Diseases and Sciences 63(7)
    • K. Matsuoka
    • Y. Uemura
    • T. Kanai
    • R. Kunisaki
    • Yasuo Suzuki
    • K. Yokoyama
    • N. Yoshimura
    • T. Hibi

Abstract

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.

Keywords: Bifidobacterium breve; Probiotics; Randomized controlled trial; Ulcerative colitis.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bifidobacterium breve BR03Altered Intestinal Microbiota CompositionNeutral
Small
Bifidobacterium breve BR03Maintained Remission in Ulcerative ColitisNeutral
Small
Bifidobacterium breve Rosell-70Altered Intestinal Microbiota CompositionNeutral
Small
Bifidobacterium breve Rosell-70Increased Adverse EventsNeutral
Small
Bifidobacterium breve Rosell-70Increased Relapse-Free Survival in Ulcerative ColitisNeutral
Small
Bifidobacterium breve SD5206Increased Relapse-Free Survival in Ulcerative ColitisNeutral
Small
Bifidobacterium breve UABbr-11Altered Intestinal Microbiota CompositionNeutral
Small
Bifidobacterium breve UABbr-11Maintained Remission in Ulcerative ColitisNeutral
Small
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