Actively Recruiting
A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms
Led by The University of Queensland · Updated on 2024-11-12
200
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
T
The University of Queensland
Lead Sponsor
P
Princess Alexandra Hospital, Brisbane, Australia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relevant, chronic, or relapsing gastrointestinal symptoms without concerning features and on the wait list for integrated care clinic
- 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
You will not qualify if you...
- Patients with alarm signs or symptoms like unexplained weight loss, gastrointestinal bleeding, iron deficiency anemia, or new onset gastrointestinal symptoms
- Patients with mild or moderate symptoms not requiring clinical work-up or likely to improve on their own
- Patients with comorbidities that interfere with the study interventions
- Patients with a prior history of eating disorders, those wait listed for bariatric surgery, or those who have had bariatric surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
Research Team
G
Gerald Holtmann, MD, PhD
CONTACT
N
Natasha Koloski, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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