Evidence map›Paper›PMID 36319696›Full record

Trial reportPediatric research2023

Functional response to a microbial synbiotic in the gastrointestinal system of children: a randomized clinical trial.

Braden T Tierney, James Versalovic, Alessio Fasano, Joseph F Petrosino, Bruno P Chumpitazi, Emeran A Mayer, Jared Boetes, Gerard Smits, Shanthi G Parkar, Noah Voreades and 7 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Pediatric research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 20% 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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Smart CaCOScientific reports · 2026
    Article
  7. Article
  8. Review
  9. Observational
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

17 authors at 6 institutions in 3 countries.

Braden T TierneyDepartment of Physiology and Biophysics, Weill Cornell Medical College, New York, NY, USA.
James VersalovicDepartment of Pathology and Immunology, Baylor College of Medicine, Houston, TX, USA.
Alessio FasanoMucosal Immunology and Biology Research Center, Center for Celiac Research and Treatment and Division of Pediatric Gastroenterology and Nutrition, Massachusetts General Hospital for Children, Boston, MA, USA.
Joseph F PetrosinoAlkek Center for Metagenomics and Microbiome Research, Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.
Bruno P ChumpitaziDepartment of Pediatrics, Baylor College of Medicine, Houston, TX, USA.
Emeran A MayerVatche and Tamar Manoukian Division of Digestive Diseases, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
Jared BoetesSeed Health, Venice, CA, USA.
Gerard SmitsSeed Health, Venice, CA, USA.
Shanthi G ParkarSeed Health, Venice, CA, USA.
Noah VoreadesSeed Health, Venice, CA, USA.
Ece KartalInstitute for Computational Biomedicine, Heidelberg University Hospital, Heidelberg, Germany.
Gabriel A Al-GhalithSeed Health, Venice, CA, USA.
Marco PaneSeed Health, Venice, CA, USA.
Peter A BronSeed Health, Venice, CA, USA.
Gregor ReidCentre for Human Microbiome and Probiotic Research, Lawson Health Research Institute, London, ON, Canada.
Raja DhirSeed Health, Venice, CA, USA. raja@seed.com.
Christopher E MasonDepartment of Physiology and Biophysics, Weill Cornell Medical College, New York, NY, USA. chm2042@med.cornell.edu.
Baylor College of Medicine · USCornell University · USCenter for Neurologic Study · USMassachusetts General Hospital · USUniversity Hospital Heidelberg · DEWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOral microbial therapy has been studied as an intervention for a range of gastrointestinal disorders. Though research suggests that microbial exposure may affect the gastrointestinal system, motility, and host immunity in a pediatric population, data have been inconsistent, with most prior studies being in neither a randomized nor placebo-controlled setting. The aim of this randomized, placebo-controlled study was to evaluate the efficacy of a synbiotic on increasing weekly bowel movements (WBMs) in constipated children.

methodsSixty-four children (3-17 years of age) were randomized to receive a synbiotic (n = 33) comprising mixed-chain length oligosaccharides and nine microbial strains, or placebo (n = 31) for 84 days. Stool microbiota was analyzed on samples collected at baseline and completion. The primary outcome was a change from baseline of WBMs in the treatment group compared to placebo.

resultsTreatment increased (p < 0.05) the number of WBMs in children with low baseline WBMs, despite broadly distinctive baseline microbiome signatures. Sequencing revealed that low baseline microbial richness in the treatment group significantly anticipated improvements in constipation (p = 0.00074).

conclusionsThese findings suggest the potential for (i) multi-species-synbiotic interventions to improve digestive health in a pediatric population and (ii) bioinformatics-based methods to predict response to microbial interventions in children. IMPACT: Synbiotic microbial treatment improved the number of spontaneous weekly bowel movements in children compared to placebo. Intervention induced an increased abundance of bifidobacteria in children, compared to placebo. All administered probiotic species were enriched in the gut microbiome of the intervention group compared to placebo. Baseline microbial richness demonstrated potential as a predictive biomarker for response to intervention.

Indexed as

ProbioticsSynbioticsChildConstipationDouble-Blind MethodFecesGastrointestinal TractHumansInfant

Identifiers

PMID36319696
PMCPMC10313516
OpenAlexW4307827212

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.