Probiotic study aims to calm irritable bowel
NCT ID NCT07584278
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a daily probiotic supplement can reduce symptoms like belly pain and bloating in people with Irritable Bowel Syndrome (IBS). About 252 adults with IBS will take either the probiotic or a placebo for 12 weeks. Researchers will track symptom changes and collect blood, stool, and saliva samples to see if the probiotic helps.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 252 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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May 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosed with IBS according to ROME V criteria * IBS-SSS greater than or equal to 75 * Adult over 18 years old * BMI 18.5-35 kg/m2 * Able to understand the participant information sheet and willing to comply with the study protocol * Able to give informed consent * Able to complete the Swedish questionnaires Exclusion Criteria: * History of any gastroenterology disease including coeliac disease, heart, liver, neurological, or current psychiatric disease, diabetes, any surgery to the abdomen that affects intestinal function (not including cholecystectomy, appendectomy, ceasarean section). * The use of opioids 1 month prior to screening and throughout the study * The use of probiotic supplements from 14days before randomization and during the study (not including foods with probiotic components) * Consumption of antibiotics 3 months prior to screening and throughout the study * The start of any new drugs that affect the gastrointestinal tract or symptoms within the last month before the start of the study. As well as the start of new diets of psychological therapy as treatment for IBS symptoms. * Participation in any medical research during the last month * Clinically relevant lab abnormalities at the time of screening (fecal calprotectin greater than or equal to 150 ug/g as absolute cutoff. If calprotectin is between 50 - 150ug/g the decision is made on clinical judgement) * Pregnancy, plan to become pregnant during the study, breastfeeding * alcohol consumption \>14 units per week * Use of recreational active drugs during 1 month before screening or during the study * Use of medication that primarily affects bowel function, transit time, stool consistency 2 weeks before the intervention or during the 12 week intervention period
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mag-tarmlab, Sahlgrenska University Hospital
RECRUITINGGothenburg, 413 45, Sweden
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Herbal capsules take on gut bacteria: a new hope for IBS?
- Could a Dual-Action supplement tame irritable bowel syndrome?
- Could an Anti-Inflammatory diet designed for Crohn's disease also tame IBS?
- Scientists hunt for the exact FODMAPs that trigger IBS pain
- Gut-Brain connection in IBS: scientists hunt for clues to anxiety and depression