Improving care for patients with severe unexplained gastrointestinal symptoms
A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms: A Randomised, Controlled Intervention to Assess Efficacy and Cost-effectiveness
This study tests whether early remote support like diet advice, exercise, or therapy can help people with ongoing unexplained stomach issues feel better before their clinic visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | The University of Queensland Academic / other |
| Locations | 1 site (Woolloongabba, Queensland) |
| Trial ID | NCT05274854 on ClinicalTrials.gov |
What this trial studies
This project tests the effectiveness of early remote interventions for patients with chronic unexplained gastrointestinal symptoms before their appointments at an integrated care clinic. Patients will first undergo a structured assessment and those with ongoing symptoms will be randomized to receive one of several pre-consultation interventions, including dietary guidance, exercise, cognitive behavioral therapy, or no intervention. Following this, they will be randomized again to either a consultant-led outpatient clinic or an integrated care clinic based on their response to the initial intervention. The study aims to evaluate both the efficacy and cost-effectiveness of these approaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with severe chronic gastrointestinal symptoms who are on the waitlist for integrated care.
Not a fit: Patients with mild or moderate symptoms or those exhibiting alarm signs will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with more effective management strategies for their chronic gastrointestinal symptoms.
How similar studies have performed: Other studies have shown promise in using structured interventions for gastrointestinal disorders, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Woolloongabba, Queensland
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (Recruiting)
Study contacts
- Principal investigator: Gerald Holtmann, MD PhD — The University of Queensland
- Study coordinator: Gerald Holtmann, MD, PhD
- Email: g.holtmann@uq.edu.au
- Phone: 61 7 3176 7792
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.