AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Probiotics and Biomarkers in Irritable Bowel Syndrome

RecruitingNAAges 18 Years - anyAllSahlgrenska University Hospital
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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 biol

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
๐Ÿ’Š

What it tests

  • Probiotic Supplementation (Lactobacillus Reuteri)
  • Placebo Supplementation
๐Ÿ“

Where

1 site
Mag-tarmlab, Sahlgrenska University Hospital
Gothenburg, Sweden
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy