Effects of carbohydrates on irritable bowel syndrome
The Effects of Fructans in Irritable Bowel Syndrome
This study tests if adding back certain carbohydrates called fructans can help people with diarrhea-predominant IBS feel better after following a low FODMAP diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Göteborg) |
| Trial ID | NCT04830410 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of carbohydrates, specifically fructans, on patients with Irritable Bowel Syndrome (IBS) characterized by diarrhea. It aims to explore how poorly absorbed carbohydrates contribute to gastrointestinal symptoms and the potential benefits of reintroducing fructans after a low FODMAP diet. The study will compare the effects of fructan reintroduction against a placebo to assess symptom improvement and changes in gut microbiota. The goal is to provide a more manageable dietary approach for IBS patients while minimizing nutritional inadequacies.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with IBS according to ROME IV criteria who experience diarrhea.
Not a fit: Patients with other gastrointestinal diseases or conditions that affect intestinal function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary recommendations for IBS patients, enhancing their quality of life.
How similar studies have performed: Previous studies on low FODMAP diets have shown promising results, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * IBS according to ROME IV criteria (with diarrhoea) Exclusion Criteria: * Celiac disease or any other gastroenterology disease (such as inflammatory bowel disease, celiac disease, microscopic colitis, diverticulitis, radiation enteritis). * Suspected or known strictures, fistulas or physiological/mechanical GI obstruction, history of gastric bezoar. * Appendicectomy and cholecystectomy \<3 months. * Heart-, liver-, neurological-, or current psychiatric disease, diabetes, obesity (BMI\>30), other disease or surgery to the abdomen that affected intestinal function. * Implantable or portable electro-mechanical medical devices, e.g. pacemakers. * Swallowing disorders/dysphagia to food or pills. * Allergy or intolerances to foods. * Compliance to a special diet (including vegan, vegetarian, gluten-free or low FODMAP diet). * Pregnant or breast feeding. * Usage of antibiotics within 4 weeks prior to inclusion * Usage of alcohol more than 14 units per week. * No new pharmacological treatment during the study period. * Medications: laxatives, neuromodulators or opioids (morphine, codeine, tramadol...)
Where this trial is running
Göteborg
- Sahlgrenska University Hospital — Göteborg, Sweden (Recruiting)
Study contacts
- Study coordinator: Magnus Simrén, MD, PhD
- Email: magnus.simren@medicine.gu.se
- Phone: +46313421000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.