Evidence map›Paper›PMID 29688915›Full record

Trial reportJournal of clinical gastroenterology2019

Clinical and Microbiological Effect of a Multispecies Probiotic Supplementation in Celiac Patients With Persistent IBS-type Symptoms: A Randomized, Double-Blind, Placebo-controlled, Multicenter Trial.

Ruggiero Francavilla, Maria Piccolo, Antonio Francavilla, Lorenzo Polimeno, Francesco Semeraro, Fernanda Cristofori, Stefania Castellaneta, Michele Barone, Flavia Indrio, Marco Gobbetti and 1 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 78 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 6 pooled it
9.1field-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.

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

78 citing papers in PubMed, 6 syntheses or guidelines pooled it, 140 citations in OpenAlex.

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  6. Bifidobacteria Was Decreased in Adult Patients With Irritable Bowel Syndrome Based on PCR and Bacterial Culture: A Systematic Review and Meta-Analysis.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2022
    Pooled it
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  8. Combined ProbioticMolecules (Basel, Switzerland) · 2026
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  11. Novel probiotic preparation withMicrobiology spectrum · 2024
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18 more citing papers are in PubMed but not listed here.

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

11 authors at 5 institutions in 3 countries.

Ruggiero FrancavillaDepartment of Interdisciplinary Medicine.
Maria PiccoloDepartment of Soil, Plant and Food Science.
Antonio FrancavillaIRCCS "Saverio De Bellis," Castellana Grotte.
Lorenzo PolimenoDepartment of Interdisciplinary Medicine.
Francesco SemeraroGastroenterology Unit, PO Centrale Taranto, Taranto.
Fernanda CristoforiDepartment of Interdisciplinary Medicine.
Stefania CastellanetaDepartment of Pediatrics, PO San Paolo, Bari.
Michele BaroneDepartment of Emergency and Organ Transplantation, University of Bari Aldo Moro.
Flavia IndrioDepartment of Interdisciplinary Medicine.
Marco GobbettiFaculty of Science and Technology, Piazza Università, Free University of Bozen, Bolzano, Italy.
Maria De AngelisDepartment of Soil, Plant and Food Science.
Free University of Bozen-Bolzano · ITGastroenterology Hospital "Saverio de Bellis" · ITInstitute of Soil Science · CNPlanta · RUUniversity of Bari Aldo Moro · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

goalsThe goals of this study were to evaluate the efficacy and safety of a probiotic mixture in patients with celiac disease (CD) with irritable bowel syndrome (IBS)-type symptoms despite a strict gluten-free diet (GFD).

backgroundAbout 30% of patients with CD adherent to a GFD suffer from IBS-type symptoms; a possible cause resides in the imbalances of the intestinal microbiota in CD. Probiotics may represent a potential treatment. STUDY: CD patients with IBS-type symptoms entered a prospective, double-blind, randomized placebo-controlled study. A 6-week treatment period was preceded by a 2-week run-in and followed by a 6-week follow-up phase. Clinical data were monitored throughout the study by validated questionnaires: IBS Severity Scoring System (IBS-SSS); Gastrointestinal Symptom Rating Scale (GSRS); Bristol Stool Form Scale (BSFS); and IBS Quality of Life Questionnaire (IBS-QOL). The fecal microbiota were assayed using plate counts and 16S rRNA gene-based analysis.

resultsIn total, 109 patients were randomized to probiotics (n=54) or placebo (n=55). IBS-SSS and GSRS decreased significantly in probiotics, as compared with placebo [(-15.9%±14.8% vs. 8.2%±25.9%; P<0.001) and (-19.8%±16.6% vs. 12.9%±31.6%; P<0.001)], respectively. Treatment success was significantly higher in patients receiving probiotics, as compared with placebo (15.3% vs. 3.8%; P<0.04). Presumptive lactic acid bacteria, Staphylococcus and Bifidobacterium, increased in patients receiving probiotic treatment. No adverse events were reported.

conclusionsA 6-week probiotic treatment is effective in improving the severity of IBS-type symptoms, in CD patients on strict GFD, and is associated with a modification of gut microbiota, characterized by an increase of bifidobacteria.

Indexed as

Diet, Gluten-FreeAdolescentAdultCeliac DiseaseDouble-Blind MethodFecesFemaleFollow-Up StudiesGastrointestinal MicrobiomeHumansIrritable Bowel SyndromeMaleMiddle AgedProbioticsProspective StudiesQuality of Life

Identifiers

PMID29688915
PMCPMC6382041
OpenAlexW2940755054

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.