Actively Recruiting
The Impact of Probiotics on Biomarkers and Symptom Severity in Irritable Bowel Syndrome
Led by Sahlgrenska University Hospital · Updated on 2026-06-01
252
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a probiotic supplement containing a new strain derived from Lactobacillus reuteri can improve symptoms and gut transit time in adults with irritable bowel syndrome (IBS). This double-blind, randomized, placebo-controlled trial aims to determine if the probiotic changes IBS symptom severity and to explore biological mechanisms and predictors of treatment response. The study involves 252 adult participants diagnosed with IBS using Rome IV criteria. Participants will be randomly assigned to receive either the probiotic supplement or a matching placebo, taken as one tablet twice daily for 12 weeks. The study includes four visits: screening and consent, randomization and start of treatment, end of intervention with data collection, and a follow-up visit three months after treatment ends. Optional procedures like rectal sensitivity tests, sigmoidoscopy, and MRI assessments may also be offered. During the study, participants will provide biological samples including blood, stool, saliva, and urine and complete various questionnaires assessing IBS symptoms, quality of life, anxiety, depression, diet, and work productivity. Researchers will monitor symptom changes throughout the intervention and at follow-up to assess the probiotic's impact on IBS severity, gastrointestinal symptoms, pain, transit time, and psychological factors. The total study duration includes 12 weeks of treatment plus a three-month post-treatment follow-up.
CONDITIONS
Brief 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 Symptom Severity Score (IBS-SSS) greater than or equal to 75
- Adult over 18 years old
- Body mass index (BMI) between 18.5 and 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, or abdominal surgery affecting intestinal function (except cholecystectomy, appendectomy, cesarean section)
- Use of opioids within 1 month prior to screening and during the study
- Use of probiotic supplements within 14 days before randomization and during the study (excluding probiotic foods)
- Use of antibiotics within 3 months prior to screening and during the study
- Starting new drugs affecting the gastrointestinal tract or symptoms, new diets, or psychological therapy for IBS symptoms within 1 month before the study
- Participation in any medical research within the last month
- Clinically relevant lab abnormalities at screening (fecal calprotectin ≥150 ug/g or clinical judgment for 50-150 ug/g)
- Pregnancy, planning pregnancy during the study, or breastfeeding
- Alcohol consumption more than 14 units per week
- Use of recreational drugs in the month before screening or during the study
- Use of medication mainly affecting bowel function, transit time, or stool consistency 2 weeks before or during the 12-week intervention period
AI-Screening
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Your Study Journey
Duration - 2 to 8 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits including consent, questionnaires, and biological samples
Duration - 12 weeks
Participants take either the probiotic supplement or placebo twice daily and complete symptom tracking and assessments.
Baseline visit, weekly symptom tracking, phone follow-up at week 6, and end-of-treatment visit
Duration - 3 months
Participants complete assessments to evaluate long-term outcomes after finishing treatment.
1 follow-up visit
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
M
MagTarmlab office
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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