Evidence map›Paper›PMID 27159972›Full record

SynthesisGenome medicine2016

Alterations in fecal microbiota composition by probiotic supplementation in healthy adults: a systematic review of randomized controlled trials.

Nadja B Kristensen, Thomas Bryrup, Kristine H Allin, Trine Nielsen, Tue H Hansen, Oluf Pedersen

Registry-linked trialOpen access · goldAbstract readSystematic Review
In one paragraph

Synthesis in Genome medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04171466 (A Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy of a Multi-strain Synbiotic), which is not on this map. Cited by 285 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
285citing papers in PubMed, 10 pooled it
28.9field-weighted citation impact, top 1% 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.

NCT04171466 nacompletednot on this mapstarted 2020, after this paper: background citation

A Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy of a Multi-strain Synbiotic (SH-DS01) to Restore Gut Barrier Integrity and Gut Microbiota Composition After Antibiotic Administration.

TypeinterventionalSponsorSeed HealthRan2020 to 2022Enrolled46ConditionsAntibiotic Side Effect, Antibiotic-associated Diarrhea, Antibiotic-induced Dysbiosis, Antibiotic-induced Epithelial Barrier DisintegrityArmsCiprofloxacin + Metronidazole, SH-DS01, Placebo
3 · Its place in the literature

Who cites it

285 citing papers in PubMed, 10 syntheses or guidelines pooled it, 547 citations in OpenAlex.

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  16. Clinical benefits ofFrontiers in nutrition · 2025
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  20. Efficacy and dose response ofWorld journal of gastroenterology · 2023
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225 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Nadja B KristensenThe Novo Nordisk Foundation Center for Basic Metabolic Research, Section of Metabolic Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 1, 2nd floor, Copenhagen Ø, 2100, Denmark. nadja@sund.ku.dk.
Thomas BryrupThe Novo Nordisk Foundation Center for Basic Metabolic Research, Section of Metabolic Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 1, 2nd floor, Copenhagen Ø, 2100, Denmark.
Kristine H AllinThe Novo Nordisk Foundation Center for Basic Metabolic Research, Section of Metabolic Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 1, 2nd floor, Copenhagen Ø, 2100, Denmark.
Trine NielsenThe Novo Nordisk Foundation Center for Basic Metabolic Research, Section of Metabolic Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 1, 2nd floor, Copenhagen Ø, 2100, Denmark.
Tue H HansenThe Novo Nordisk Foundation Center for Basic Metabolic Research, Section of Metabolic Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 1, 2nd floor, Copenhagen Ø, 2100, Denmark.
Oluf PedersenThe Novo Nordisk Foundation Center for Basic Metabolic Research, Section of Metabolic Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 1, 2nd floor, Copenhagen Ø, 2100, Denmark.
University of Copenhagen · DKNovo Nordisk Foundation · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe effects of probiotic supplementation on fecal microbiota composition in healthy adults have not been well established. We aimed to provide a systematic review of the potential evidence for an effect of probiotic supplementation on the composition of human fecal microbiota as assessed by high-throughput molecular approaches in randomized controlled trials (RCTs) of healthy adults.

methodsThe survey of peer-reviewed papers was performed on 17 August 2015 by a literature search through PubMed, SCOPUS, and ISI Web of Science. Additional papers were identified by checking references of relevant papers. Search terms included healthy adult, probiotic, bifidobacterium, lactobacillus, gut microbiota, fecal microbiota, intestinal microbiota, intervention, and (clinical) trial. RCTs of solely probiotic supplementation and placebo in healthy adults that examined alteration in composition of overall fecal microbiota structure assessed by shotgun metagenomic sequencing, 16S ribosomal RNA sequencing, or phylogenetic microarray methods were included. Independent collection and quality assessment of studies were performed by two authors using predefined criteria including methodological quality assessment of reports of the clinical trials based on revised tools from PRISMA/Cochrane and by the Jadad score.

resultsSeven RCTs investigating the effect of probiotic supplementation on fecal microbiota in healthy adults were identified and included in the present systematic review. The quality of the studies was assessed as medium to high. Still, no effects were observed on the fecal microbiota composition in terms of α-diversity, richness, or evenness in any of the included studies when compared to placebo. Only one study found that probiotic supplementation significantly modified the overall structure of the fecal bacterial community in terms of β-diversity when compared to placebo.

conclusionsThis systematic review of the pertinent literature demonstrates a lack of evidence for an impact of probiotics on fecal microbiota composition in healthy adults. Future studies would benefit from pre-specifying the primary outcome and transparently reporting the results including effect sizes, confidence intervals, and P values as well as providing a clear distinction of between-group and within-group comparisons.

Indexed as

AdultBacteriaFecesHealthy VolunteersHumansMicrobiotaPhylogenyProbioticsRandomized Controlled Trials as Topic

Identifiers

PMID27159972
PMCPMC4862129
OpenAlexW2343150225

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.