Genetic Carbohydrate Maldigestion As Model to Study Food Hypersensitivity Mechanism (WORK PACKAGE 2)

Launched by UNIVERSITY OF NOTTINGHAM · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to understand how certain genetic factors affect gastrointestinal symptoms in people who have a condition called Sucrase Isomaltase Deficiency (CSID). The study aims to see how the gut responds to sucrose, a type of sugar, in individuals with different genetic variations related to carbohydrate digestion. Researchers believe that some people with Irritable Bowel Syndrome (IBS) may experience symptoms when they eat certain carbohydrates because their bodies do not break them down properly. By studying this, the trial hopes to find personalized dietary treatments that could help those suffering from IBS and related digestive issues.

To participate in this trial, you need to be at least 18 years old and meet specific criteria. For those with CSID, you should have a confirmed genetic diagnosis and must not have any other serious gastrointestinal diseases. Healthy participants can also join, but they must not have any functional or organic gastrointestinal disorders. Participants will undergo tests that include an MRI and a breath test to assess how their bodies react to sucrose. If you're interested in this study, it’s a chance to help researchers learn more about food sensitivities and improve treatment options for people with IBS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for CSID subjects:
• • Aged ≥18 (all groups)
• • Subjects with genetically proven CSID
• • Previous negative endoscopy with biopsies excluding IBD or microscopic colitis in people above 50 years old.
• • Negative relevant additional screening (including exclusion of coeliac disease with TTG and IgA)
• • Ability to conform to the study protocol including the sucrose challenge.
• Exclusion Criteria for CSID subjects:
• • Subjects on opioids and use of drugs known to alter GI motility for the duration of the study.
• • Presence of concurrent organic gastrointestinal disease (inflammatory bowel disease, coeliac disease, cancer), or a major disease such as diabetes, uncontrolled thyroid disease
• • Any history of bowel surgery (not appendectomy or cholecystectomy)
• • Contraindication to MRI scanning
• • Having taken part in another interventional research study within 3 months
• • Concurrent major confounding condition (e.g. alcohol or substance abuse in the last 2 years) based on the study clinician's judgement.
• Inclusion Criteria for healthy participants:
• • Aged ≥18 years
• • Absence of Rome III IBS criteria
• • Non-SI variant confirmed (group 1) or Single-SI variants confirmed (group 2) or Double - SI variants confirmed (group 3)
• • Ability to conform to the study protocol including the sucrose challenge
• Exclusion Criteria for healthy participants:
• • Person presenting with a functional or organic GI disorder.
• • Person presenting with underlying disease that may involve the GI tract (e.g. Parkinson's disease) or be associated with GI symptoms (e.g. anorexia nervosa, major depression).
• • Any history of bowel surgery (not appendectomy or cholecystectomy)
• • Contraindication to MRI scanning
• • Having taken part in another interventional research study within 3 months
• • Concurrent major confounding condition (e.g. alcohol or substance abuse in the last 2 years) based on the clinician's judgement.