NCT07584278 Probiotics and Biomarkers in Irritable Bowel Syndrome
| NCT ID | NCT07584278 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sahlgrenska University Hospital |
| Condition | Irritable Bowel Syndrome (IBS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 252 participants |
| Start Date | 2026-04-28 |
| Primary Completion | 2031-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 252 participants in total. It began in 2026-04-28 with a primary completion date of 2031-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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
Contact & Investigator
Magnus Simren, MD PHD
PRINCIPAL INVESTIGATOR
Göteborg University
Frequently Asked Questions
Who can join the NCT07584278 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Irritable Bowel Syndrome (IBS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07584278 currently recruiting?
Yes, NCT07584278 is actively recruiting participants. Contact the research team at magnus.simren@medicine.gu.se for enrollment information.
Where is the NCT07584278 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT07584278 clinical trial?
NCT07584278 is sponsored by Sahlgrenska University Hospital. The principal investigator is Magnus Simren, MD PHD at Göteborg University. The trial plans to enroll 252 participants.