Probiotics and Biomarkers in Irritable Bowel Syndrome
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
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- Who runs it
- Sahlgrenska University Hospital
- Trial code
- NCT07584278
- Record updated
- 1 June 2026
- Original description
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:Read full original descriptionShow less
The Impact of Probiotics on Biomarkers and Symptom Severity in Irritable Bowel Syndrome
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
Inclusion: 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: The use of opioids 1 month prior to screening and throughout the study; 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; 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; 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 probiotic supplements from 14days before randomization and during the study (not including foods with probiotic components); 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.