Evidence map›Paper›PMID 35596146›Full record

ArticleBMC gastroenterology2022

Protocol of a randomized, double-blind, placebo-controlled study of the effect of probiotics on the gut microbiome of patients with gastro-oesophageal reflux disease treated with rabeprazole.

Wenjun Liu, Yong Xie, Yingmeng Li, Longjin Zheng, Qiuping Xiao, Xu Zhou, Qiong Li, Ni Yang, Kexuan Zuo, Tielong Xu and 2 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC gastroenterology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.5field-weighted citation impact, top 19% 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, 9 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  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

12 authors at 5 institutions in 1 country.

Wenjun Liu *Key Laboratory of Dairy Biotechnology and Engineering, Key Laboratory of Dairy Products Processing, Inner Mongolia Key Laboratory of Dairy Biotechnology and Engineering, Inner Mongolia Agricultural University, Ministry of Education, Ministry of Agriculture and Rural Affairs, Hohhot, 010018, China.
Yong Xie *Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, China.
Yingmeng Li *State Key Laboratory of Innovative Medicines and High-Efficiency Energy-Saving Pharmaceutical Equipment, Nanchang, 330006, China.
Longjin ZhengState Key Laboratory of Innovative Medicines and High-Efficiency Energy-Saving Pharmaceutical Equipment, Nanchang, 330006, China.
Qiuping XiaoState Key Laboratory of Innovative Medicines and High-Efficiency Energy-Saving Pharmaceutical Equipment, Nanchang, 330006, China.
Xu ZhouEvidence Based Medicine Research Center, Jiangxi University of Chinese Medicine, Nanchang, 330004, China.
Qiong LiEvidence Based Medicine Research Center, Jiangxi University of Chinese Medicine, Nanchang, 330004, China.
Ni YangState Key Laboratory of Innovative Medicines and High-Efficiency Energy-Saving Pharmaceutical Equipment, Nanchang, 330006, China.
Kexuan ZuoState Key Laboratory of Innovative Medicines and High-Efficiency Energy-Saving Pharmaceutical Equipment, Nanchang, 330006, China.
Tielong XuEvidence Based Medicine Research Center, Jiangxi University of Chinese Medicine, Nanchang, 330004, China. jxciq_xtl@126.com.
Nong-Hua LuDepartment of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, China. lunonghua@ncu.edu.cn.
Heping ZhangKey Laboratory of Dairy Biotechnology and Engineering, Key Laboratory of Dairy Products Processing, Inner Mongolia Key Laboratory of Dairy Biotechnology and Engineering, Inner Mongolia Agricultural University, Ministry of Education, Ministry of Agriculture and Rural Affairs, Hohhot, 010018, China. hepingdd@vip.sina.com.
Shanghai Innovative Research Center of Traditional Chinese Medicine · CNJiangxi University of Traditional Chinese Medicine · CNFirst Affiliated Hospital of Nanchang University · CNInner Mongolia Agricultural University · CNMinistry of Agriculture and Rural Affairs · CN

Funding

National Natural Science Foundation of China 31720103911
6 · The paper itself

Abstract

backgroundFor patients with gastro-oesophageal reflux symptoms, the preferred treatment is proton pump inhibitor (PPI) administration for approximately 8 weeks. However, long-term use of PPIs can cause gut microbiome (GM) disturbances. This study is designed to evaluate the effect of probiotics combined with a PPI on the GM and gastrointestinal symptoms of patients with gastro-oesophageal reflux disease (GERD).

methodThis is a randomized, double-blind, placebo-controlled trial. A total of 120 eligible patients with GERD will be randomized into the experimental group or the control group. The treatment includes two phases: the initial treatment period lasts 8 weeks (weeks 1-8), and the maintenance treatment period lasts 4 weeks (weeks 9-12). During the initial treatment period, the experimental group will take rabeprazole and LiHuo probiotics, and the control group will take rabeprazole and a probiotic placebo; during the maintenance treatment period, the experimental group will take LiHuo probiotics, and the control group will take a probiotic placebo. The primary measure is the change in the GM. The secondary measures are the Reflux Disease Questionnaire (RDQ) score, Gastrointestinal Symptom Rating Scale (GSRS) score, faecal metabolome (FM), body mass index, Los Angeles grade of oesophagitis, adverse event (AE) rate and treatment compliance. Each outcome indicator will be assessed at day 0 (before administration), day 28 and/or 56 (during administration), and day 84 (end of administration) to reveal intragroup differences. AEs will be monitored to assess the safety of LiHuo probiotics. DISCUSSION: This will be the first trial to use the intestinal flora metagene method to analyse the effects of probiotics on patients with GERD receiving long-term PPI treatment. The goal is to provide evidence for the use of probiotics to reduce intestinal flora disorders and other symptoms of gastrointestinal discomfort in patients with GERD who have used PPIs for a long period.

trial registrationChinese Clinical Trial Registry (ChiCTR) (NO. ChiCTR2000038409). Registered on November 22, 2020, http://www.chictr.org.cn/showproj.aspx?proj=56358 .

Indexed as

Gastroesophageal RefluxGastrointestinal MicrobiomeProbioticsDouble-Blind MethodHumansProton Pump InhibitorsRabeprazoleRandomized Controlled Trials as TopicTreatment OutcomeProton Pump InhibitorsRabeprazoleGERDGut microbiomeProbioticsProton pump inhibitors

Identifiers

PMID35596146
PMCPMC9123715
OpenAlexW4281261553

What Socratic 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 Socratic graph.