Exploring how genetic carbohydrate maldigestion relates to food hypersensitivity

Genetic Carbohydrate Maldigestion as a Model to Study Food Hypersensitivity Mechanism and Guide Personalised Treatment Using a Non-invasive Multiparametric Test (Work Package 1)

This study is trying to see if there's a link between genetic issues with digesting carbohydrates and food sensitivities in people aged 5 to 70 who have Irritable Bowel Syndrome.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 5 Years to 70 Years
• Sex: All
• Sponsor: Nottingham University Hospitals NHS Trust (Academic / other)
• Locations: 1 site (Nottingham)
• Trial ID: NCT05795049 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between genetic carbohydrate maldigestion and food hypersensitivity in patients with Irritable Bowel Syndrome (IBS). It focuses on individuals aged 5 to 70 who experience IBS-D or IBS-M symptoms, utilizing stool and saliva sample collection along with questionnaires to gather data. The study aims to understand how certain carbohydrates may trigger gastrointestinal symptoms and why some patients respond to dietary interventions like the low-FODMAP diet while others do not. By examining these factors, the research seeks to shed light on the underlying causes of IBS symptoms and improve therapeutic options.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 5 to 70 with IBS-D or IBS-M who have previously undergone negative endoscopy to rule out other gastrointestinal diseases.

Not a fit: Patients with IBS-C or IBS-U, as well as those with significant concurrent gastrointestinal or major diseases, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better dietary recommendations and treatments for patients suffering from IBS.

How similar studies have performed: While the relationship between carbohydrate maldigestion and IBS has been explored, this specific approach focusing on genetic factors is relatively novel.

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).

Where this trial is running

Nottingham

• Nottingham University Hospitals NHS Trust — Nottingham, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Maura Corsetti, MD

Conditions Irritable Bowel Syndrome; Sucrase Isomaltase Deficiency; nutrigenetics; carbohydrates maldigestion