Efficacy of Bifidobacterium breve Fermented Milk in Maintaining Remission of Ulcerative Colitis - PubMed (original) (raw)

Randomized Controlled Trial

. 2018 Jul;63(7):1910-1919.

doi: 10.1007/s10620-018-4946-2. Epub 2018 Feb 15.

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Randomized Controlled Trial

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

Katsuyoshi Matsuoka et al. Dig Dis Sci. 2018 Jul.

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.

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Conflict of interest statement

Takanori Kanai received a financial donation from Yakult. Yasuo Suzuki, Toshifumi Hibi, Yukari Uemura, Kaoru Yokoyama, Naoki Yoshimura, Reiko Kunisaki, and Katsuyoshi Matsuoka have no conflicts of interest to declare.

Figures

Fig. 1

Fig. 1

Study flowchart. Some patients discontinued for more than one reason. 5-ASA 5-aminosalicylic acid, BFM Bifidobacterium breve strain Yakult fermented milk, FAS full analysis set, PPS per-protocol set

Fig. 2

Fig. 2

Relapse-free survival rate during the study period (48 weeks after enrollment). BFM Bifidobacterium breve strain Yakult fermented milk

Fig. 3

Fig. 3

Bifidobacterium levels in the relapse (exa) versus remission (remi) groups. †P < 0.063, **P = 0.006 by Mann–Whitney U test

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