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

Launched by THE UNIVERSITY OF QUEENSLAND · Mar 8, 2022

Keywords

ClinConnect Summary

This clinical trial is looking to find out if early remote support can help patients who have severe, ongoing gastrointestinal symptoms that doctors cannot easily explain. The study will first assess patients' symptoms and check for wheat intolerance remotely. If symptoms persist, participants will be randomly assigned to one of several options before their regular doctor visit: they might receive guidance from a dietitian on what to eat, take part in an exercise program, try online therapy to change their thinking about health, or not receive any additional intervention at all. After this initial phase, patients will have another appointment that could either be with a regular consultant or a specialized care team, depending on how they respond to the first intervention.

To be eligible for this study, participants need to be aged between 18 and 90 and have severe gastrointestinal symptoms, as defined by a specific scoring system. However, those with concerning symptoms, such as significant weight loss or gastrointestinal bleeding, will need to see a doctor urgently before joining the study. The trial is currently recruiting participants, and it offers an opportunity for those struggling with unexplained GI issues to explore different management strategies in a supportive setting.

Gender

ALL

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