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Probiotics and Biomarkers in Irritable Bowel Syndrome

NCT07584278 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2026-06-01

No results posted yet for this study

Summary

The goal of this double-blind parallel-arm randomized controlled trial is to learn if a probiotic supplement (containing a new strain derived from L. reuteri) alters outcomes related to symptom severity and transit time in adults with irritable bowel syndrome (IBS). The main question it aims to answer is:

Does the probiotic alter IBS symptom severity?

Researchers will compare the probiotic to a placebo (a lookalike substance that contains no probiotic) to see if the probiotic works to alter outcomes.

Participants will:

Be randomized to either take the probiotic supplement or placebo supplement daily for 12 weeks.

Visit the lab for 4 study visits (visit 1: screening and informed consent; visit 2: randomization, data collection, beginning the intervention; visit 3: end of intervention and data collection; visit 4: 3 month post intervention follow up and data collection).

Provide biological samples (blood, stool, saliva, urine) Complete questionnaires

Conditions

  • Irritable Bowel Syndrome (IBS)

Interventions

OTHER

Probiotic Supplementation (Lactobacillus Reuteri)

Probiotic using a new strain derived from L. reuteri.

OTHER

Placebo Supplementation

A placebo supplement that is identical to the probiotic in formulation and packaging except that the probiotic bacteria is not present.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Magnus Simren, MD PHD · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-28
Primary Completion
2031-04-30
Completion
2031-05-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07584278 on ClinicalTrials.gov