Actively Recruiting
Probiotics and Biomarkers in Irritable Bowel Syndrome
Led by Sahlgrenska University Hospital · Updated on 2026-05-13
252
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 DSM 17938) 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
Official Title
Probiotics and Biomarkers in Irritable Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mag-tarmlab, Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Actively Recruiting
Research Team
M
Magnus Simren, MD, PhD
CONTACT
M
MagTarmlab office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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