Genetic Carbohydrate Maldigestion as a Model to Study Food Hypersensitivity

Launched by NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST · Mar 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a condition called Irritable Bowel Syndrome (IBS), which affects many people and causes uncomfortable symptoms like stomach pain, bloating, and changes in bowel habits. Researchers want to understand how a specific genetic issue related to carbohydrate digestion might contribute to these symptoms. They are particularly interested in patients who have IBS with diarrhea (IBS-D) or mixed symptoms (IBS-M). By comparing these patients with healthy individuals who do not have IBS, the study aims to find out how common this genetic alteration is among those with IBS.

To be eligible for this study, participants should be between 5 and 70 years old and have been diagnosed with IBS-D or IBS-M. They must also have had tests to rule out other gastrointestinal diseases. Unfortunately, those with certain other conditions, such as constipation-predominant IBS (IBS-C) or other serious health issues, cannot participate. If chosen, participants will take part in assessments that may help improve understanding of IBS and potentially lead to better treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for Patients:
• • Patients age between 5 and 70 years of age.
• • Patients with IBS-D or IBS-M as defined by the Rome III criteria.
• • Previous negative endoscopy with biopsies excluding IBD or microscopic colitis in patients above 50 years old
• • Negative relevant additional screening or consultation whenever appropriate
• • Ability to conform to the study protocol
• Exclusion Criteria for Patients:
• • Patients with IBS-C or IBS-U according to Rome III criteria
• • Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for participation in the study.
• • Patients on opioids
• • Patients with concurrent organic gastrointestinal disease (inflammatory bowel disease, celiac disease, cancer), or a major disease such as diabetes, uncontrolled thyroid disease
• • Patients with a history of bowel surgery (not appendectomy or cholecystectomy)
• • Concurrent major confounding condition, e.g. alcohol or substance abuse in the last 2 years (clinician's judgement).
• Inclusion Criteria for healthy controls:
• • Between 5 and 70 years of age
• • Absence of Rome III IBS criteria
• Exclusion Criteria for healthy controls:
• • Blood relatives of the participating IBS patient are not allowed to participate.
• • Person with any condition which, in the opinion of the investigator, makes them unsuitable for participation in the study.
• • 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).