Evidence map›Paper›PMID 40431448›Full record

Trial reportNutrients2025

Multistrain Probiotics Plus Vitamin D Improve Gut Barrier Function and Gut Microbiota Composition in Irritable Bowel Syndrome Without Constipation: Results from a Double-Blind, Randomized, Placebo-Controlled Trial.

Lucrezia Laterza, Cesare Cremon, Gaetano Coppola, Carlo Romano Settanni, Rossella Maresca, Martina Strazzeri, Eleonora Durini, Valentina Petito, Franco Scaldaferri, Giorgio Gargari and 9 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Nutrients, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–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.

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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. The bile acid-gut microbiota-vitamin D axis: new insights into biliary atresia.Frontiers in cellular and infection microbiology · 2026
    Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. 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

19 authors.

Lucrezia LaterzaCEMAD Digestive Disease Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.ORCID 0000-0001-5515-1197
Cesare CremonDepartment of Medical and Surgical Sciences, University of Bologna, 40100 Bologna, Italy.ORCID 0000-0002-7777-2936
Gaetano CoppolaCEMAD Digestive Disease Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.
Carlo Romano SettanniUnit of Gastroenterology and Digestive Endoscopy, Scientific Institute for Research, Hospitalization and Healthcare (IRCCS) Italian National Research Centres on Aging (INRCA), 60100 Ancona, Italy.
Rossella MarescaCEMAD Digestive Disease Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.ORCID 0000-0002-1472-0039
Martina StrazzeriCEMAD Digestive Disease Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.
Eleonora DuriniCEMAD Digestive Disease Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.
Valentina PetitoCeMAD Translational Research Laboratories, Digestive Disease Center (CeMAD), Department of Medical and Surgical Sciences, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, 00146 Rome, Italy.
Franco ScaldaferriCEMAD Digestive Disease Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.ORCID 0000-0001-8334-7541
Giorgio GargariDepartment of Food, Environmental and Nutritional Sciences (DeFENS), University of Milan, 20121 Milan, Italy.ORCID 0000-0001-9077-6328
Diego MoraDepartment of Food, Environmental and Nutritional Sciences (DeFENS), University of Milan, 20121 Milan, Italy.ORCID 0000-0002-6692-9301
Elnaz Vojoudi YazdiDepartment of Food, Environmental and Nutritional Sciences (DeFENS), University of Milan, 20121 Milan, Italy.
Chiara MarangeloUnit of Microbiome, Bambino Gesù Children's Hospital, IRCCS, 00146 Rome, Italy.ORCID 0000-0002-6633-3938
Gianluca IaniroCEMAD Digestive Disease Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.
Lorenza PutignaniUnit of Microbiomics and Unit of Microbiome, Bambino Gesù Children's Hospital, IRCCS, 00146 Rome, Italy.ORCID 0000-0003-0134-2830
Maria Raffaella BarbaroDepartment of Medical and Surgical Sciences, University of Bologna, 40100 Bologna, Italy.
Giovanni MarascoDepartment of Medical and Surgical Sciences, University of Bologna, 40100 Bologna, Italy.ORCID 0000-0001-7167-8773
Giovanni BarbaraDepartment of Medical and Surgical Sciences, University of Bologna, 40100 Bologna, Italy.
Antonio GasbarriniCEMAD Digestive Disease Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.ORCID 0000-0002-6230-1779

Funding

Beingpharma no number
6 · The paper itself

Abstract

backgroundThe disruption of the intestinal barrier and the imbalance of the gut microbiota (GM) seem to play a major role in the complex pathogenesis of irritable bowel syndrome (IBS). Specific microbial strains could improve the gut microenvironment, promoting anti-inflammatory pathways; similarly, vitamin D supplementation could play a role in enhancing the barrier integrity and modulating the immune response in the gut. This study aims to evaluate the efficacy of a new multistrain probiotic, combined with vitamin D, in improving gut barrier function in IBS without constipation.

methodsIn this phase IIb double-blind randomized placebo-controlled, parallel-group, multicenter, clinical trial, 35 patients were treated for 12 weeks with OttaBac

resultsMean zonulin values showed a significant progressive reduction in the active group (-10.2 ng/mL at week 12,

conclusionsProbiotic plus vitamin D could improve IBS-associated symptoms through gut microbiota modulation and gut barrier enhancement, with persistent benefits after treatment discontinuation.

Indexed as

CholecalciferolGastrointestinal MicrobiomeIntestinal MucosaIrritable Bowel SyndromeProbioticsVitamin DAdultConstipationDouble-Blind MethodFecesFemaleHaptoglobinsHumansMaleMiddle AgedPermeabilityCholecalciferolHaptoglobinsProtein PrecursorsVitamin Dzonulingut barrierIBSprobiotic

Identifiers

PMID40431448
PMCPMC12114473

What OpenQuestion holds

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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.