Evidence map›Paper›PMID 21436726›Full record

Trial reportJournal of clinical gastroenterology2011

Probiotic bacteria Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 versus placebo for the symptoms of bloating in patients with functional bowel disorders: a double-blind study.

Tamar Ringel-Kulka, Olafur S Palsson, Danielle Maier, Ian Carroll, Joseph A Galanko, Gregory Leyer, Yehuda Ringel

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical gastroenterology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02204891 (A Clinical Study of the Efficacy of a Formulation of Four Probiotics in Patients With Syndrome of Intestinal Bacterial Overgrowth and Irritable Bowel Syndrome), which is not on this map. Cited by 88 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed, 6 pooled it
10.0field-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.

NCT02204891 nacompletednot on this mapstarted 2014, after this paper: background citation

A Clinical Study of the Efficacy of a Formulation of Four Probiotics in Patients With Syndrome of Intestinal Bacterial Overgrowth and Irritable Bowel Syndrome

TypeinterventionalSponsorUniversity of AthensRan2014 to 2016Enrolled26ConditionsIrritable Bowel SyndromeArmsProbiotics in SIBO, Probiotics
3 · Its place in the literature

Who cites it

88 citing papers in PubMed, 6 syntheses or guidelines pooled it, 170 citations in OpenAlex.

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  10. Bacillus Subtilis (BG01-4Nutrients · 2023
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  12. Nutrients · 2020
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28 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Tamar Ringel-KulkaGillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Olafur S Palsson
Danielle Maier
Ian Carroll
Joseph A Galanko
Gregory Leyer
Yehuda Ringel
University Gastroenterology · USUniversity of North Carolina at Chapel Hill · US

Funding

Zonisamide in Patients with Neuropathic Pain Associated with Diabetic NeuropathyM01RR000046 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI JOY, MELANIE S · 1985 to 2008
$38.5M
PILOT AND FEASIBILITY STUDIESP30DK034987 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ROBERT S. SANDLER · 1985 to 2026
$30.5M
The Role of Intestinal Inflammation in the Pathophysiology of IBSK23DK075621 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI RINGEL, YEHUDA · 2006 to 2010
$786k
NCRR NIH HHS M01 RR000046NCRR NIH HHS RR00046NIDDK NIH HHS DK034987NIDDK NIH HHS K23 DK075621
6 · The paper itself

Abstract

backgroundRecent data suggest a role for the intestinal microbiota in the pathogenesis of functional bowel disorders (FBDs). Probiotic studies in FBDs generated inconsistent results suggesting a strain-specific and product-specific effect.

aimTo investigate the clinical efficacy of Lactobacillus acidophilus NCFM (L-NCFM) and Bifidobacterium lactis Bi-07 (B-LBi07) in nonconstipation FBDs.

methodsA double-blind, placebo-control clinical trial of the probiotic bacterias L-NCFM and B-LBi07 twice a day (2×10(11) CFU/d) versus placebo over 8 weeks. Primary endpoints were global relief of gastrointestinal symptoms and satisfaction with treatment. Secondary endpoints were change in symptoms severity, well-being, and quality of life. Microbiological effect was assessed by quantitative real time polymerase chain reaction on fecal samples.

resultsSixty patients (probiotic, n=31; placebo, n=29), 72% females, 84% whites, mean age 37 years. Abdominal bloating improved in the probiotics compared with the placebo group at 4 weeks (4.10 vs 6.17, P=0.009; change in bloating severity P=0.02) and 8 weeks (4.26 vs 5.84, P=0.06; change in bloating severity P<0.01). Analyses on the irritable bowel syndrome subgroup (n=33) showed similar results.

conclusionsL-NCFM and B-LBi07 twice a day improve symptoms of bloating in patients with FBDs. These data supports the role of intestinal bacteria in the pathophysiology of FBD and the role for probiotic bacteria in the management of these disorders.

Indexed as

AdultBifidobacteriumDouble-Blind MethodFecesFemaleFlatulenceHumansIntestinesIrritable Bowel SyndromeLactobacillus acidophilusMaleMiddle AgedPlacebosProbioticsTreatment OutcomePlacebos

Identifiers

PMID21436726
PMCPMC4372813
OpenAlexW2009129153

What OpenQuestion holds

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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 OpenQuestion graph.