Evidence map›Paper›PMID 29801486›Full record

Trial reportBMC gastroenterology2018

A randomized placebo-controlled clinical trial of a multi-strain probiotic formulation (Bio-Kult®) in the management of diarrhea-predominant irritable bowel syndrome.

Shamsuddin M Ishaque, S M Khosruzzaman, Dewan Saifuddin Ahmed, Mukesh Prasad Sah

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 62 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 10 pooled it
7.2field-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.

NCT03251625 phase4completednot on this map

Supplementation With a Multi-strain Probiotic Formulation (Bio-Kult®) in the Management of Diarrhea-predominant Irritable Bowel Syndrome - a Randomized, Double-blind, Placebo-controlled Clinical Trial

TypeinterventionalSponsorBangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshRan2015 to 2016Enrolled400ConditionsIrritable Bowel SyndromeArmsProbiotic Formula Capsule
NCT05174273 phase2 / phase3active not recruitingnot on this mapstarted 2022, after this paper: background citation

Understanding the Neurocognitive Effects of Fecal Microbiota Transplantation in Major Depressive Disorder Patients With and Without Irritable Bowel Syndrome

TypeinterventionalSponsorValerie TaylorRan2022 to 2026Enrolled133ConditionsMajor Depressive Disorder, Irritable Bowel SyndromeArmsFecal Microbiota Transplantation
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 10 syntheses or guidelines pooled it, 102 citations in OpenAlex.

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  10. Efficacy and safety of probiotics in irritable bowel syndrome: A systematic review and meta-analysis.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association
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  12. Effect of PostbioticNutrients · 2024
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  15. Efficacy and dose response ofWorld journal of gastroenterology · 2023
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2 more citing papers are in PubMed but not listed here.

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

4 authors at 1 institution in 1 country.

Shamsuddin M IshaqueDepartment of Gastroenterology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. s.md.ishaque@gmail.com.ORCID http://orcid.org/0000-0002-9715-4852
S M KhosruzzamanDepartment of Gastroenterology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
Dewan Saifuddin AhmedDepartment of Gastroenterology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
Mukesh Prasad SahDepartment of Gastroenterology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
Bangladesh Medical University · BD

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAccumulating evidence supports the view that an imbalance of gut bacteria contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers of pathogenic bacteria and help alleviate symptoms.

methodsIn this double-blind trial 400 adult patients with moderate-to-severe symptomatic diarrhea-predominant IBS (IBS-D) were randomized to treatment with the multi-strain probiotic Bio-Kult® (14 different bacterial strains) or placebo for 16 weeks. The change in severity and frequency of abdominal pain was the primary outcome measure.

resultsProbiotic treatment significantly improved the severity of abdominal pain in patients with IBS-D. A 69% reduction for probiotic versus 47% for placebo (p < 0.001) equates to a 145 point reduction on the IBS-severity scoring system (IBS-SSS). The proportion of patients who rated their symptoms as moderate-to-severe was reduced from 100% at baseline to 14% for the multi-strain probiotic at follow-up (month 5) versus 48% for placebo (p < 0.001). Also, the number of bowel motions per day from month 2 onwards was significantly reduced in the probiotic group compared with the placebo group (p < 0.05). In addition to relieving symptoms, the probiotic markedly improved all dimensions of quality of life in the 34-item IBS-Quality of Life (IBS-QoL) questionnaire. No serious adverse events were reported.

conclusionsThe multi-strain probiotic was associated with significant improvement in symptoms in patients with IBS-D and was well-tolerated. These results suggest that probiotics confer a benefit in IBS-D patients which deserves further investigation.

trial registration[Clinicaltrials.gov NCT03251625 ; retrospectively registered on August 9, 2017].

Indexed as

Abdominal PainAdolescentAdultDiarrheaDouble-Blind MethodFemaleGastrointestinal MicrobiomeHumansIrritable Bowel SyndromeMaleMiddle AgedProbioticsQuality of LifeSeverity of Illness IndexYoung AdultBioKultDiarrheaGastrointestinal well-beingIBSMulti-strain probioticProbioticQuality of lifeRandomized controlled trial

Identifiers

PMID29801486
PMCPMC5970461
OpenAlexW2807175397

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.