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

NCT05274854 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-11-12

No results posted yet for this study

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.

Conditions

  • Gastrointestinal Diseases
  • Irritable Bowel Syndrome

Interventions

BEHAVIORAL

a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing

Pre consultation interventions consist of one of four intervention a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing

BEHAVIORAL

a) consultant-led outpatient clinic or b) a integrated care clinic

Consultation intervention consists of one of two interventions a) consultant-led outpatient clinic or b) a integrated care clinic

Sponsors & Collaborators

  • Princess Alexandra Hospital, Brisbane, Australia

    collaborator OTHER

  • Macquarie University, Australia

    collaborator OTHER

  • The University of Queensland

    lead OTHER

Principal Investigators

  • Gerald Holtmann, MD PhD · The University of Queensland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2025-10-30
Completion
2025-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05274854 on ClinicalTrials.gov