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

StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 12, 2024 (before its estimated October 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Primary completion date: Oct 30, 2024 to Oct 30, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 10, 2023 to May 1, 2023
    • Study sites: 0 to 1
    • Primary completion date: Oct 2024 to Oct 30, 2024
    v3
  4. Start date: Mar 21, 2022 to Jan 10, 2023v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05274854
Lead Sponsor The University of Queensland
Collaborators: Princess Alexandra Hospital, Brisbane, Australia, Macquarie University, Australia
Conditions
(from sponsor)		 Gastrointestinal Diseases, Irritable Bowel Syndrome
Related terms Gastrointestinal Diseases, Irritable Bowel Syndrome
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov