Evidence map›Paper›PMID 32605578›Full record

ArticleTrials2020

The efficacy of Bifidobacterium quadruple viable tablet in the treatment of diarrhea predominant irritable bowel syndrome: protocol for a randomized, double-blind, placebo-controlled, multicenter trial.

Tao Bai, Haoyu Zeng, Yanqin Long, Xiaoqing Li, Xiaohong Sun, Yu Lan, Lingling Gao, Lu Zhang, Zenghui Feng, Xiaohua Hou

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 1 country.

Tao BaiDivision of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Jiefang Avenue, Wuhan, Hubei, China.
Haoyu ZengDivision of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Jiefang Avenue, Wuhan, Hubei, China.
Yanqin LongDivision of Gastroenterology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, 3 East Qingchun Road, Hangzhou, Zhejiang, China.
Xiaoqing LiDivision of Gastroenterology, Peking Union Medical College Hospital, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, China.
Xiaohong SunDivision of Gastroenterology, Peking Union Medical College Hospital, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, China.
Yu LanDivision of Gastroenterology, Beijing Jishuitan Hospital, Xicheng District Xinjiekou No. 31 East Street, Beijing, China.
Lingling GaoPeking University Clinical Research Institute, No.38 Xueyuan Road, Haidian District, Beijing, China.
Lu ZhangHangzhou Grand Biologic Pharmaceutical. INC, 63 Jiuhuan Road, Jianggan District, Hangzhou, Zhejiang, China.
Zenghui FengHangzhou Grand Biologic Pharmaceutical. INC, 63 Jiuhuan Road, Jianggan District, Hangzhou, Zhejiang, China.
Xiaohua HouDivision of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Jiefang Avenue, Wuhan, Hubei, China. houxh@hust.edu.cn.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNHuazhong University of Science and Technology · CNPeking University · CNZhejiang Hisun Pharmaceutical (China) · CNUnion Hospital · CNZhejiang University · CN

Funding

Hangzhou Grand Biologic Pharmaceutical. INC N/A
6 · The paper itself

Abstract

backgroundIrritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits. Leading to significant negative effect on patients' quality of life and huge financial burden to health system, the management of IBS is a great challenge. Probiotics are considered as an effective therapy; however, in a lack of high-quality evidence of efficacy, no strain- and dose-specific probiotics were recommended in clinical guidelines. This study aims to evaluate the efficacy of the Bifidobacterium quadruple viable tablet in the treatment of IBS-D. METHODS/

designA multicenter randomized controlled trial will be performed in fourteen hospitals. A total of three hundred patients who fulfill the eligibility criteria will be stratified divided into an experimental group and a control group randomly in a ratio of 1:1. The experimental group is treated with the Bifidobacterium quadruple viable tablet while the control group is treated with placebo. All the patients will receive a 4-week treatment and a 2-week follow-up. The primary outcome is the effectiveness in improving abdominal pain and stool consistency; the secondary outcome includes evaluation of overall symptom relief, frequency of defecation, bloating, urgency of defecation, remedial medication, score of IBS-QOL, and changes of microbiota and metabonomics. Physical examination, vital signs, laboratory tests, adverse events, and concomitant medication will be taken into account for intervention safety assessment during the trial. DISCUSSION: This multicenter randomized controlled trial may provide high-quality evidence on the efficacy of the Bifidobacterium quadruple viable tablet for IBS-D on both physical and mental dimensions in China. To fill the gap of previous probiotic intervention studies, in addition, this study will also present safety assessment which will be a significant emphasis.

trial registrationChiCTR1800017721 . Registered on 10 August 2018.

Indexed as

BifidobacteriumChinaDiarrheaDouble-Blind MethodFecesHumansIrritable Bowel SyndromeMulticenter Studies as TopicProbioticsQuality of LifeRandomized Controlled Trials as TopicSeverity of Illness IndexTabletsTreatment OutcomeTabletsDiarrhea predominant IBSEfficacyIrritable bowel syndromeProbioticsRandomized controlled trial

Identifiers

PMID32605578
PMCPMC7329396
OpenAlexW3040082816

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.