Evidence map›Paper›PMID 29450747›Full record

Trial reportDigestive diseases and sciences2018

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

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 71 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 10 pooled it
7.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 10 syntheses or guidelines pooled it, 124 citations in OpenAlex.

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  8. Probiotics for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020
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11 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 8 institutions in 1 country.

Katsuyoshi MatsuokaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Yukari UemuraBiostatistics Division, Central Coordinating Unit, Clinical Research Support Center, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.
Takanori KanaiDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Reiko KunisakiInflammatory Bowel Disease Center, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.
Yasuo SuzukiInternal Medicine, Toho University Sakura Medical Center, 564-1 Shimoshizu, Sakura, Chiba, 285-8741, Japan.
Kaoru YokoyamaDepartment of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan.
Naoki YoshimuraDepartment of Internal Medicine, Division of IBD, Tokyo Yamate Medical Center, 3-22-1 Hyakunincho, Shinjuku-ku, Tokyo, 169-0073, Japan.
Toshifumi HibiCenter for Advanced Inflammatory Bowel Disease Research and Treatment, Kitasato University Kitasato Institute Hospital, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8642, Japan. thibi@insti.kitasato-u.ac.jp.
Keio University · JPKitasato Institute Hospital · JPKitasato University · JPToho University Medical Center Sakura Hospital · JPTokyo Medical and Dental University · JPTokyo Yamate Medical Center · JPUniversity of Tokyo Hospital · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFermented milk products containing Bifidobacterium breve strain Yakult (BFM) may improve clinical status in ulcerative colitis (UC) patients.

aimsTo assess efficacy of BFM in maintaining remission in Japanese patients with quiescent UC.

methodsThis 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).

resultsAn 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).

conclusionsBFM had no effect on time to relapse in UC patients compared with placebo. STUDY REGISTRATION: UMIN000007593.

Indexed as

Gastrointestinal MicrobiomeAdultAgedBifidobacterium breveColitis, UlcerativeCultured Milk ProductsDisease-Free SurvivalDouble-Blind MethodFemaleHumansIntestinesJapanLactobacillus acidophilusMaleMiddle AgedRecurrenceBifidobacterium breveProbioticsRandomized controlled trialUlcerative colitis

Identifiers

PMID29450747
PMCPMC6015104
OpenAlexW2789624862

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.