NCT05274854 A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms
| NCT ID | NCT05274854 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Queensland |
| Condition | Gastrointestinal Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2025-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-05-01 with a primary completion date of 2025-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients with relevant, chronic, or relapsing gastrointestinal (GI) symptoms without concerning features and on the wait list for integrated care clinic (ICC) will be included in the study. * Patients with severe symptoms as defined by a total Structured Assessment of Gastrointestinal Symptoms (SAGIS) score \> 35 * Patients aged 18 years or older to 90 years old Exclusion Criteria: * Patients with 'alarm' signs or symptoms (significant unexplained weight loss, evidence for gastrointestinal bleeding, iron deficiency anaemia, new onset GI symptoms) will be triaged to undergo urgent clinical work-up before they can be considered for inclusion into the study * Patients with mild or moderate symptoms (e.g. not requiring clinical work-up or who will likely spontaneously improve) will not be eligible for inclusion into the study and will be managed as clinically indicated. * Patients with any comorbidities that would interfere with the objectives of these interventions will be managed via the routine clinical pathways. * Patients with a prior history of any eating disorder, wait listed for bariatric surgery or have had bariatric surgery will be excluded
Contact & Investigator
Gerald Holtmann, MD PhD
PRINCIPAL INVESTIGATOR
The University of Queensland
Frequently Asked Questions
Who can join the NCT05274854 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Gastrointestinal Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05274854 currently recruiting?
Yes, NCT05274854 is actively recruiting participants. Contact the research team at g.holtmann@uq.edu.au for enrollment information.
Where is the NCT05274854 trial being conducted?
This trial is being conducted at Woolloongabba, Australia.
Who is sponsoring the NCT05274854 clinical trial?
NCT05274854 is sponsored by The University of Queensland. The principal investigator is Gerald Holtmann, MD PhD at The University of Queensland. The trial plans to enroll 200 participants.