Evidence map›Paper›PMID 27595104›Full record

Trial reportBioMed research international2016

A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation.

Valerio Mezzasalma, Enrico Manfrini, Emanuele Ferri, Anna Sandionigi, Barbara La Ferla, Irene Schiano, Angela Michelotti, Vincenzo Nobile, Massimo Labra, Patrizia Di Gennaro

Erratum issued 3 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BioMed research international, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 52 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 12 pooled it
4.0field-weighted citation impact, top 6% 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.

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
NCT06636513 narecruitingnot on this mapstarted 2024, after this paper: background citation

A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 in Irritable Bowel Syndrome (IBS)

TypeinterventionalSponsorChangi General HospitalRan2024 to 2026Enrolled40ConditionsIrritable Bowel SyndromeArmsSMT04 (M3XTRA)
NCT06647043 narecruitingnot on this mapstarted 2025, after this paper: background citation

A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 Pro in Irritable Bowel Syndrome (IBS)

TypeinterventionalSponsorUniversiti Sains MalaysiaRan2025 to 2025Enrolled20ConditionsIrritable Bowel Syndrome (IBS)ArmsSMT04 Pro
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 12 syntheses or guidelines pooled it, 78 citations in OpenAlex.

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  12. 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
    Pooled it
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  14. Efficacy ofNutrients · 2024
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  20. All Properties of Infertility Microbiome in a Review Article.Journal of clinical laboratory analysis · 2025
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Valerio MezzasalmaDepartment of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126 Milan, Italy.ORCID 0000-0001-7651-4567
Enrico ManfriniDepartment of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126 Milan, Italy.
Emanuele FerriDepartment of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126 Milan, Italy.
Anna SandionigiDepartment of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126 Milan, Italy.ORCID 0000-0002-5257-0027
Barbara La FerlaDepartment of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126 Milan, Italy.
Irene SchianoFarcoderm Srl., Via Angelini 21, San Martino Siccomario, 27028 Pavia, Italy.
Angela MichelottiFarcoderm Srl., Via Angelini 21, San Martino Siccomario, 27028 Pavia, Italy.
Vincenzo NobileFarcoderm Srl., Via Angelini 21, San Martino Siccomario, 27028 Pavia, Italy.
Massimo LabraDepartment of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126 Milan, Italy.ORCID 0000-0003-1065-5804
Patrizia Di GennaroDepartment of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126 Milan, Italy.ORCID 0000-0002-0865-7627
University of Milano-Bicocca · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background and Aim. The efficacy of supplementation treatment with two multispecies probiotic formulates on subjects diagnosed with IBS-C and the assessment of their gut microbiota were investigated. Methods. A randomized, double-blind, three-arm parallel group trial was carried out on 150 IBS-C subjects divided into three groups (F_1, F_2, and F_3). Each group received a daily oral administration of probiotic mixtures (for 60 days) F_1 or F_2 or placebo F_3, respectively. Fecal microbiological analyses were performed by species-specific qPCR to assess the different amount of probiotics. Results. The percentage of responders for each symptom was higher in the probiotic groups when compared to placebo group during the treatment period (t60) and was maintained quite similar during the follow-up period (t90). Fecal analysis demonstrated that probiotics of the formulations increased during the times of treatment only in fecal DNA from subjects treated with F_1 and F_2 and not with F_3, and the same level was maintained during the follow-up period. Conclusions. Multispecies probiotic supplementations are effective in IBS-C subjects and induce a different assessment in the composition of intestinal microbiota. This clinical study is registered with the clinical study registration number ISRCTN15032219.

Indexed as

Dietary SupplementsAdolescentAdultAgedConstipationDouble-Blind MethodFemaleFollow-Up StudiesHumansIrritable Bowel SyndromeMaleMiddle AgedProbiotics

Identifiers

PMID27595104
PMCPMC4993960
OpenAlexW2510462781

What OpenQuestion holds

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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.