NCT05274854

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 12, 2024

Status Verified

September 1, 2024

Enrollment Period

2.5 years

First QC Date

February 7, 2022

Last Update Submit

November 10, 2024

Conditions

Gastrointestinal DiseasesIrritable Bowel Syndrome

Outcome Measures

Primary Outcomes (25)

  • Structured Assessment of Gastrointestinal Symptoms score

    Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms

    Week 0

  • Structured Assessment of Gastrointestinal Symptoms score

    Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms

    Week 8

  • Structured Assessment of Gastrointestinal Symptoms score

    Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms

    Week 16

  • Structured Assessment of Gastrointestinal Symptoms score

    Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms

    Week 20

  • Structured Assessment of Gastrointestinal Symptoms score

    Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms

    Week 24

  • Structured Assessment of Gastrointestinal Symptoms score

    Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms

    Week 28

  • Structured Assessment of Gastrointestinal Symptoms score

    Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms

    Week 32

  • Structured Assessment of Gastrointestinal Symptoms score

    Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms

    Week 35

  • Structured Assessment of Gastrointestinal Symptoms score

    Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms

    Week 38

  • Structured Assessment of Gastrointestinal Symptoms score

    Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms

    Week 44

  • European Quality of Life Five Dimension (EQ-5D)

    The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state

    Week 0

  • European Quality of Life Five Dimension (EQ-5D)

    The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state

    Week 8

  • European Quality of Life Five Dimension (EQ-5D)

    The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state

    Week 16

  • European Quality of Life Five Dimension (EQ-5D)

    The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state

    Week 20

  • European Quality of Life Five Dimension (EQ-5D)

    The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state

    Week 24

  • European Quality of Life Five Dimension (EQ-5D)

    The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state

    Week 28

  • European Quality of Life Five Dimension (EQ-5D)

    The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state

    Week 32

  • European Quality of Life Five Dimension (EQ-5D)

    The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state

    Week 35

  • European Quality of Life Five Dimension (EQ-5D)

    The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state

    Week 38

  • European Quality of Life Five Dimension (EQ-5D)

    The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state

    Week 44

  • Cost effectiveness

    To assess the cost-effectiveness and given the expected impact of the intervention on patient quality of life, a cost-utility analysis (CUA) will be conducted. The analysis will capture direct medical and non- medical costs including out-of-pocket expenses and indirect costs (e.g., lost productivity) based upon resources consumed using unit prices from standard costing resources. Quality-adjusted life-year (QALYs) gained will be weighted by their utility score (using the EQ-5D)

    Week 0

  • Cost effectiveness

    To assess the cost-effectiveness and given the expected impact of the intervention on patient quality of life, a cost-utility analysis (CUA) will be conducted. The analysis will capture direct medical and non- medical costs including out-of-pocket expenses and indirect costs (e.g., lost productivity) based upon resources consumed using unit prices from standard costing resources. Quality-adjusted life-year (QALYs) gained will be weighted by their utility score (using the EQ-5D)

    Week 8

  • Cost effectiveness

    To assess the cost-effectiveness and given the expected impact of the intervention on patient quality of life, a cost-utility analysis (CUA) will be conducted. The analysis will capture direct medical and non- medical costs including out-of-pocket expenses and indirect costs (e.g., lost productivity) based upon resources consumed using unit prices from standard costing resources. Quality-adjusted life-year (QALYs) gained will be weighted by their utility score (using the EQ-5D)

    Week 16

  • Cost effectiveness

    To assess the cost-effectiveness and given the expected impact of the intervention on patient quality of life, a cost-utility analysis (CUA) will be conducted. The analysis will capture direct medical and non- medical costs including out-of-pocket expenses and indirect costs (e.g., lost productivity) based upon resources consumed using unit prices from standard costing resources. Quality-adjusted life-year (QALYs) gained will be weighted by their utility score (using the EQ-5D)

    Week 28

  • Cost effectiveness

    To assess the cost-effectiveness and given the expected impact of the intervention on patient quality of life, a cost-utility analysis (CUA) will be conducted. The analysis will capture direct medical and non- medical costs including out-of-pocket expenses and indirect costs (e.g., lost productivity) based upon resources consumed using unit prices from standard costing resources. Quality-adjusted life-year (QALYs) gained will be weighted by their utility score (using the EQ-5D)

    Week 44

Secondary Outcomes (10)

  • Hospital Anxiety and Depression Scale

    Week 0

  • Hospital Anxiety and Depression Scale

    Week 16

  • Hospital Anxiety and Depression Scale

    Week 28

  • Hospital Anxiety and Depression Scale

    Week 44

  • Microbiome

    Week 0

  • +5 more secondary outcomes

Study Arms (2)

Preconsultation Intervention

EXPERIMENTAL

Pre-consultation intervention includes 4 arms ((a) standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing)

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

Consultation Intervention

EXPERIMENTAL

Consultation intervention includes 2 arms (a) consultant-led outpatient clinic or b) a integrated care clinic depending on their response to the initial preconsultation intervention.

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

Interventions

a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothingBEHAVIORAL

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

Preconsultation Intervention
a) consultant-led outpatient clinic or b) a integrated care clinicBEHAVIORAL

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

Consultation Intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

MeSH Terms

Conditions

Gastrointestinal DiseasesIrritable Bowel Syndrome

Interventions

Fumigant 93

Condition Hierarchy (Ancestors)

Digestive System DiseasesColonic Diseases, FunctionalColonic DiseasesIntestinal Diseases

Study Officials

  • Gerald Holtmann, MD PhD

    The University of Queensland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerald Holtmann, MD, PhD

CONTACT

61 7 3176 7792g.holtmann@uq.edu.au

Natasha Koloski, PhD

CONTACT

0407126897n.koloski@uq.edu.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor will be blinded to the treatment groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: An Effectiveness-Implementation Hybrid Design with a two stage randomisation will be used to determine and compare efficacy and cost-effectiveness of different management approaches/interventions. Patients will initially receive standardised assessment of symptoms and wheat intolerance. Those patients that continue to experience symptoms will then be randomised to one of four pre-consultation interventions followed by randomisation to one of two consultation interventions conditional on their response to the initial intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2022

First Posted

March 11, 2022

Study Start

May 1, 2023

Primary Completion

October 30, 2025

Study Completion

December 31, 2025

Last Updated

November 12, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Deidentified group data will be analysed and published in medical journals

Locations

AU(1)