A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms

This research project aims to test whether early interventions delivered remotely and prior to integrated care clinic appointments are effective. Patients with chronic unexplained gastrointestinal symptoms will initially undergo structured assessment of symptoms and wheat intolerance delivered remotely. Patients who continue to experience symptoms will then be randomised to a pre-consultation intervention ((a) standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing) followed by randomisation to the consultation intervention ((a) consultant-led outpatient clinic or b) a integrated care clinic depending on their response to the initial intervention.

NCT Number	NCT05274854
Lead Sponsor	The University of Queensland Collaborators: Princess Alexandra Hospital, Brisbane, Australia, Macquarie University, Australia
Conditions	Gastrointestinal Diseases, Irritable Bowel Syndrome
Enrollment	200 participants
Start Date	2023-05-01
Primary Completion	2025-10-30 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-11-12