Evidence map›Paper›PMID 41233756›Full record

Trial reportBMC gastroenterology2025

Inulin-induced improvements on bowel habit and gut microbiota in adults with functional constipation: findings of a randomized, double-blind, placebo-controlled study.

Marie-Luise Puhlmann, Carrie A M Wegh, Sofie C C van der Zalm, Veerle Dam, Andrea Doolan, Diederick Meyer, Clara Belzer, Elaine E Vaughan, Marc A Benninga, Hauke Smidt

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05447481 (A Randomized Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Effects of Chicory Inulin-type Fructans in Adults With Functional Constipation), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT05447481 nacompletednot on this map

A Randomized Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Effects of Chicory Inulin-type Fructans in Adults With Functional Constipation

TypeinterventionalSponsorSensusRan2015 to 2016Enrolled40ConditionsConstipation - FunctionalArmschicory inulin-type fructan
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
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.

Marie-Luise PuhlmannLaboratory of Microbiology, Wageningen University & Research, Wageningen, The Netherlands. mlp@nexs.ku.dk.
Carrie A M WeghLaboratory of Microbiology, Wageningen University & Research, Wageningen, The Netherlands.
Sofie C C van der ZalmLaboratory of Microbiology, Wageningen University & Research, Wageningen, The Netherlands.
Veerle DamSensus B.V. (Royal Cosun), Roosendaal, The Netherlands.
Andrea DoolanAtlantia Clinical Trials, Cork, Ireland.
Diederick MeyerSensus B.V. (Royal Cosun), Roosendaal, The Netherlands.
Clara BelzerLaboratory of Microbiology, Wageningen University & Research, Wageningen, The Netherlands.
Elaine E VaughanSensus B.V. (Royal Cosun), Roosendaal, The Netherlands.
Marc A BenningaEmma Children's Hospital, Amsterdam UMC, University of Amsterdam, Department of Pediatric Gastroenterology and Nutrition, Amsterdam, The Netherlands.
Hauke SmidtLaboratory of Microbiology, Wageningen University & Research, Wageningen, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFunctional constipation is a common disorder of the gut-brain interaction characterized by infrequent bowel movements and hard stools, which substantially affects patients' quality of life. Supplementation with gut microbiome-targeted prebiotics is a promising non-pharmacological alternative to current treatments.

methodsIn a randomized, double-blind, placebo-controlled, cross-over trial, we investigated the effect of four-week daily 12 g chicory inulin intake in 39 individuals, with functional constipation according to Rome III criteria. We assessed stool frequency and consistency, constipation-related quality of life (PAC-QOL) and symptoms (PAC-SYM), and microbiota composition through 16S rRNA gene sequencing of fecal samples.

resultsAfter inulin intake, we observed larger changes in stool frequency, abdominal symptoms, and particularly social and emotional well-being related to quality of life, compared to placebo. Additionally, relative abundances of putative butyrate-producing Anaerostipes spp. and Coprococcus 1 spp. were higher. Further investigation, however, pointed to a carry-over whereby half of the participants receiving inulin in the first period had the largest improvements in all outcomes during inulin intake. Moreover, these same participants had higher baseline relative abundances of butyrate-producing Faecalibacterium spp. and Roseburia spp., and lower baseline relative abundances of Bifidobacterium spp. In turn, these participants' microbiota responded more strongly to inulin intake through a stronger increase in the relative abundance of Bifidobacterium spp. and Anaerostipes spp. To address this apparent carry-over induced bias, we analyzed the first period alone as a parallel trial which supported the observed positive effect of inulin, also affirming its established bifidogenic effect.

conclusionsDaily intake of 12 g inulin improves functional constipation by increasing stool frequency, positively affecting abdominal symptoms and well-being, and modulating the gut microbiota towards higher relative abundances of butyrate-producing genera.

trial registrationEthical approval was obtained from the Cork Research Ethics Committee of the Cork Teaching Hospitals (Reference ECM 4 (v) 01/09/15), and the trial design was retrospectively registered at ClinicalTrials.gov (NCT05447481; 07/2022).

Indexed as

ConstipationDefecationGastrointestinal MicrobiomeInulinPrebioticsAdultCross-Over StudiesDouble-Blind MethodFecesFemaleHumansMaleMiddle AgedQuality of LifeInulinPrebioticsCross-over designDisorders of gut-brain interactionGut-brain axisGut microbiomeInulinNon-pharmacological treatmentPrebiotics

Identifiers

PMID41233756
PMCPMC12613575

What Socratic holds

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LicenceCC BY-NC-ND
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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 Socratic graph.