Probiotics and Biomarkers in Irritable Bowel Syndrome
ConditionIrritable Bowel Syndrome (IBS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Probiotic Supplementation (Lactobacillus Reuteri)
- Placebo Supplementation
Treatment groups
252 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov