Evidence map›Paper›PMID 24853043›Full record

Trial reportAlimentary pharmacology & therapeutics2014

Lactobacillus acidophilus NCFM affects colonic mucosal opioid receptor expression in patients with functional abdominal pain - a randomised clinical study.

T Ringel-Kulka, J R Goldsmith, I M Carroll, S P Barros, O Palsson, C Jobin, Y Ringel

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01064661 (Physiological Effects of Probiotic Bacteria Lactobacillus Acidophilus NCFM Alone Versus a Combination With Bifidobacterium Lactids - LBi07 in Patients With Mild to Moderate Abdominal Pain/Discomfort and Bloating), which is not on this map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
3.1field-weighted citation impact, top 9% 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.

NCT01064661 nacompletednot on this map

Physiological Effects of Probiotic Bacteria Lactobacillus Acidophilus NCFM Alone Versus a Combination With Bifidobacterium Lactids - LBi07 in Patients With Mild to Moderate Abdominal Pain/Discomfort and Bloating

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2010 to 2012Enrolled22ConditionsAbdominal Pain, Abdominal Discomfort, Bloating, Functional Bowel DisordersArmsSingle probiotic arm of L-NCFM alone, Blend probiotic arm of L-NCFM and B-LBi07
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 69 citations in OpenAlex.

  1. Altered molecular signature of the intestinal microbiota in irritable bowel syndrome patients versus healthy controls: An updated systematic review.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026
    Pooled it
  2. Pooled it
  3. Enterochromaffin Cells: Sentinels to Gut Microbiota in Hyperalgesia?Frontiers in cellular and infection microbiology · 2021
    Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Nutrients · 2020
    Trial
  8. Trial
  9. Trial
  10. Abdominal Pain After Bariatric Surgery and the Role of the Gut: A Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026
    Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. A Synbiotic Combining Chitin-Glucan andInternational journal of molecular sciences · 2024
    Article
  17. Probiotics in Postoperative Pain Management.Journal of personalized medicine · 2023
    Review
  18. Review
  19. Review
  20. 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

7 authors at 2 institutions in 1 country.

T Ringel-KulkaDepartment of Maternal and Child Health, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
J R Goldsmith
I M Carroll
S P Barros
O Palsson
C Jobin
Y Ringel
University of North Carolina at Chapel Hill · USUniversity of Florida · US

Funding

PILOT AND FEASIBILITY STUDIESP30DK034987 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Temitope O. Keku · 1985 to 2026
$30.5M
The role of klebsiella pneumonia-derived colibactin in colitis-associated colon cancerR01DK073338 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI JOBIN, CHRISTIAN · 2007 to 2023
$5.4M
REGULATION OF IMMUNOSUPPRESSIVE MOLECULES IN IBDR01DK047700 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI JOBIN, CHRISTIAN · 1993 to 2014
$3.2M
The Role of Intestinal Inflammation in the Pathophysiology of IBSK23DK075621 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI RINGEL, YEHUDA · 2006 to 2010
$786k
Inflammatory Effect of Enteric Bacterial-Mediated Intestinal PermeabilityK01DK092330 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CARROLL, IAN MICHAEL · 2011 to 2015
$597k
Fecal Microflora in Irritable Bowel Syndrome (IBS): Characterization and SignificR03DK084294 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI RINGEL, YEHUDA · 2010 to 2011
$147k
The role of the mu-Opioid Receptor in Inflammatory Bowel Disease Pathology and ThF30DK085906 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI GOLDSMITH, JASON R. · 2010 to 2013
$96k
Intramural NIH HHSNIDDK NIH HHS F30 DK085906NIDDK NIH HHS F30DK085906NIDDK NIH HHS K01 DK092330NIDDK NIH HHS K23 DK075621NIDDK NIH HHS P30 DK034987NIDDK NIH HHS R01 DK047700NIDDK NIH HHS R01DK047700NIDDK NIH HHS R01 DK073338NIDDK NIH HHS R01DK073338NIDDK NIH HHS R03 DK084294PHS HHS R01 PA 10-067
6 · The paper itself

Abstract

backgroundIn a recent double-blinded clinical trial, the probiotic combination of Lactobacillus acidophilus NCFM (L-NCFM) and B-LBi07 reduced bloating symptoms in patients with functional bowel disorders; an effect more evident in those who reported abdominal pain. In mice, L-NCFM but not B-LBi07 induced colonic mu-opioid receptor (MOR) and cannabinoid receptor 2 (CB2) expression, and reduced visceral sensitivity.

aimsTo determine if L-NCFM was the active component in the clinical trial and to investigate the mechanism of action in humans with mild to moderate abdominal pain.

methodsCaucasian women (n = 20) 18-70 years with mild to moderate abdominal pain were enrolled in a double-blind, two-armed, single-centre study. Patients were given either L-NCFM alone or in combination with B-LBi07 for 21 days at a total dose of 2 × 10(10) CFU b.d. Colonic biopsies were collected during unsedated, unprepped flexible sigmoidoscopy before and at the end of probiotic consumption. mRNA and immunostaining were then performed on these biopsies. Patients kept symptom diaries for the 7 days prior to starting probiotic therapy and for the last 7 days of therapy.

resultsL-NCFM alone, but not with B-LBi07, induced colonic MOR mRNA and protein expression, as well as downstream signalling, as measured by enterocyte STAT3-phosphorylation. In contrast, CB2 expression was decreased. Both treatment groups trended towards improvement in symptoms, but the study was insufficiently powered to draw meaningful conclusions.

conclusionsLactobacillus acidophilus NCFM modulates mu-opioid receptor expression and activity, while the combination of L-NCFM and B-LBi07 does not. This study provides a possible mechanism for action by which probiotics modulates pain sensation in humans (Clinical Trial Number: NCT01064661).

Indexed as

Lactobacillus acidophilusAbdominal PainAdolescentAdultAgedColonDouble-Blind MethodEnterocytesFemaleHumansIntestinal MucosaMiddle AgedProbioticsReceptor, Cannabinoid, CB2Receptors, Opioid, muRNA, MessengerReceptor, Cannabinoid, CB2Receptors, Opioid, muRNA, MessengerSTAT3 protein, humanSTAT3 Transcription Factor

Identifiers

PMID24853043
PMCPMC4613798
OpenAlexW1967772118

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.