Irritable bowel syndrome (IBS) is a functional disorder causing troublesome symptoms and reduced quality of life. It affects 10-20% of the population, hence creates large costs for society. About 30-40% of all IBS patients do not benefit from current treatment options. Sucrase-isomaltase (SI) deficiency is an unexplored condition, that may explain symptoms in IBS patients who experience no effect from today's treatments. Currently, a duodenal biopsy is the gold standard for the diagnosis of SI deficiency, however the condition is not well investigated. A 13C-labelled breath test holds promise as a non-invasive alternative, but it has not previously been validated.
This project will address the knowledge gap related to a possible association between SI deficiency and IBS by addressing two research questions that have never been answered before. We aim to:
1. Validate the 13C-labelled breath test as a diagnostic tool by assessing the strength of the association between the breath test and SI activity measured in duodenal biopsies 2. Use the 13C-labelled breath test in a randomized dietary crossover trial comparing a starch and sucrose reduced diet (SSRD) with the standard low-FODMAP diet in IBS patients, to evaluate whether SI activity is associated with dietary changes according to symptom severity and gut microbiota composition
Signed informed consent
BMI 18-30 kg/m2
Referred for gastroscopic examination with suspected GI disorder
Signed informed consent
BMI 18-30 kg/m2
IBS diagnosis according to Rome IV criteria
Inflammatory bowel disease, celiac disease or diabetes mellitus
Crossover
Low-FODMAP diet
Other intervention4 weeks of a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs)
Starch- and Sucrose Reduced Diet (SSRD)
Other intervention4 weeks of a diet low in starch and sucrose
IBS symptom severity
Symptom severity measured by the IBS-Symptom Severity Scale (IBS-SSS)
Gut microbiota composition
Analysis of fecal samples for evaluation of microbiota composition in fecal samples collected at baseline and after each 4-week diet intervention
Fecal fermentation measured by short chain fatty acids (SCFAs)
Analysis of SCFAs in fecal samples collected at baseline and after each 4-week diet intervention
Quality of life in IBS
Assessment of quality of life by the Patient Reported Outcome Measurement Information System (PROMIS-29)
Click on the lead sponsor to view all of their trials.
Lovisenberg Diakonale Hospital
Lead sponsor
University of Bergen
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
