BridgeMD
New treatment option for Irritable Bowel Syndrome (IBS)
Official title Probiotics and Biomarkers in Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT07584278
What this study is testing
- What it's testing
- 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).
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- History of any gastroenterology disease including coeliac disease, heart, liver, neurological, or current psychiatric disease, diabetes, any surgery...
- 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...
- Participation in any medical research during the last month
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.