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

Katsuyoshi Matsuoka, Yukari Uemura, Takanori Kanai, Reiko Kunisaki, Yasuo Suzuki, Kaoru Yokoyama, Naoki Yoshimura, Toshifumi Hibi

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1-10
Number of pages10
JournalDigestive Diseases and Sciences
DOIs
Publication statusAccepted/In press - 2018 Feb 15

Fingerprint

Ulcerative Colitis
Milk
Recurrence
Placebos
Beverages
Cultured Milk Products
Lactobacillus acidophilus
Remission Induction
Bifidobacterium
Survival
Bifidobacterium breve
Double-Blind Method
Hemorrhage
Bacteria
Incidence
Therapeutics

Keywords

  • Bifidobacterium breve
  • Probiotics
  • Randomized controlled trial
  • Ulcerative colitis

ASJC Scopus subject areas

  • Physiology
  • Gastroenterology

Cite this

Efficacy of Bifidobacterium breve Fermented Milk in Maintaining Remission of Ulcerative Colitis. / Matsuoka, Katsuyoshi; Uemura, Yukari; Kanai, Takanori; Kunisaki, Reiko; Suzuki, Yasuo; Yokoyama, Kaoru; Yoshimura, Naoki; Hibi, Toshifumi.

In: Digestive Diseases and Sciences, 15.02.2018, p. 1-10.

Research output: Contribution to journalArticle

Matsuoka, Katsuyoshi ; Uemura, Yukari ; Kanai, Takanori ; Kunisaki, Reiko ; Suzuki, Yasuo ; Yokoyama, Kaoru ; Yoshimura, Naoki ; Hibi, Toshifumi. / Efficacy of Bifidobacterium breve Fermented Milk in Maintaining Remission of Ulcerative Colitis. In: Digestive Diseases and Sciences. 2018 ; pp. 1-10.
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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.",
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