NCT04373304

The Effect of a Low FODMAP Diet in Irritable Bowel Syndrome Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Tertiary care IBS patients will be recruited for a prospective low FODMAP intervention study, hereby focusing on the reintroduction phase of the diet, where patients are blindly challenged with different FODMAP groups administered as powder, to be added to the strict FODMAP exclusion phase. During the screening phase of two weeks, baseline data regarding psychological, nutritional, microbial, and genetics will be collected. Predictors of treatment response (a 50-point drop on the IBS-severity scoring system (IBS-SSS) during the strict FODMAP exclusion phase of 6 weeks) will be studied with linear mixed models.

Conditions

• Irritable Bowel Syndrome
• FODMAP

Interventions

Type	Name	Description
OTHER	low FODMAP diet	A diet specifically developed for the management of IBS is the low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, And Polyols (FODMAP) diet. FODMAP is a collective term that includes fructose in excess of glucose, oligosaccharides including fructans/fructo-oligosaccharides (FOS), galacto-oligosaccharides, sugar polyols such as sorbitol and mannitol, and lactose. Controlled studies have established efficacy of the low FODMAP in managing IBS symptoms, but this diet is complex, associated with low calorie intake, and requires individualized explanation and follow-up by an experienced dietician.

Timeline

• Start date: 2019-11-25
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2020-05-04
• Last updated: 2020-05-08

Locations

1 site across 1 country: Belgium