Gastrointestinal DiseasesNCT05274854
A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms
A study testing a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing and a) consultant-led outpatient clinic or b) a integrated care clinic in people with Gastrointestinal Diseases and Irritable Bowel Syndrome, run by The University of Queensland at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastrointestinal Diseases, Irritable Bowel Syndrome
- What is being tested?
- a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing and a) consultant-led outpatient clinic or b) a integrated care clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- 1 May 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Gerald Holtmann, PhD, 07 3176 7792, g.holtman@uq.edu.au
Natasha Koloski, PhD, 0407126897, n.koloski@uq.edu.au
About this study
Official title: A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms: A Randomised, Controlled Intervention to Assess Efficacy and Cost-effectiveness
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.
Read the detailed description
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 for patients with relevant, chronic, or relapsing gastrointestinal symptoms without concerning features and on the wait list for integrated care clinic at the Princess Alexandra Hospital. Approximately 200 patients will initially receive standardised assessment of symptoms and wheat intolerance. Those patients that 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) an integrated care clinic conditional on their response to the initial intervention. Specific aims of the study include Aim 1: Determine efficacy (symptom improvement) and cost-effectiveness (quality adjusted life years) of a structured, digital technology enabled approach for the management of patients with severe functional gastrointestinal disorders as compared to established service models; Aim 2: Identify response-predictors for the pre-clinical dietary intervention, internet delivered cognitive behavior therapy, exercise physiology and the various clinical interventions; Aim 3: Define acceptance of consumers and staff for the new service model relative to established models of care and Aim 4. To determine the dietary patterns of people with functional gastrointestinal disorders who are presenting with symptoms necessary to access tertiary care and to further examine changes in diet after a range of interventions delivered by telehealth.
- Being tested
- a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing, a) consultant-led outpatient clinic or b) a integrated care clinic
- Medical subject headings
- Gastrointestinal Diseases, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothingBehavioural
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
a) consultant-led outpatient clinic or b) a integrated care clinicBehavioural
Consultation intervention consists of one of two interventions a) consultant-led outpatient clinic or b) a integrated care clinic
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Behavioral: a) consultant-led outpatient clinic or b) a integrated care clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Week 44
Secondary outcomes (10)
Hospital Anxiety and Depression Scale
Anxiety and Depression scores from the Hospital Anxiety and Depression Scale. Scores can range from 0 to 21 for each subscale of anxiety and depression, respectively. Higher scores indicate greater frequency of anxiety and depression.
Measured: Week 0
Hospital Anxiety and Depression Scale
Anxiety and Depression scores from the Hospital Anxiety and Depression Scale. Scores can range from 0 to 21 for each subscale of anxiety and depression, respectively. Higher scores indicate greater frequency of anxiety and depression.
Measured: Week 16
Hospital Anxiety and Depression Scale
Anxiety and Depression scores from the Hospital Anxiety and Depression Scale. Scores can range from 0 to 21 for each subscale of anxiety and depression, respectively. Higher scores indicate greater frequency of anxiety and depression.
Measured: Week 28
Hospital Anxiety and Depression Scale
Anxiety and Depression scores from the Hospital Anxiety and Depression Scale. Scores can range from 0 to 21 for each subscale of anxiety and depression, respectively. Higher scores indicate greater frequency of anxiety and depression.
Measured: Week 44
Microbiome
Total abundance and relative abundance of specific phyla of the microbiome
Measured: Week 0
Microbiome
Total abundance and relative abundance of specific phyla of the microbiome
Measured: Week 16
Microbiome
Total abundance and relative abundance of specific phyla of the microbiome
Measured: Week 28
Microbiome
Total abundance and relative abundance of specific phyla of the microbiome
Measured: Week 44
Acceptance of models of care by consumers and staff
For the pre-consultation and the 3- months intervention period, the consumer's net promotor score ('…I would recommend the service I received to a family member or friend yes/no..') will be determined and compared. With regard to the team providing services to the patients, all members providing care will respond to the following question in relation to specific treatment groups: '...I have been able to address the patient's problems yes/no..'
Measured: Week 16
Acceptance of models of care by consumers and staff
For the pre-consultation and the 3- months intervention period, the consumer's net promotor score ('…I would recommend the service I received to a family member or friend yes/no..') will be determined and compared. With regard to the team providing services to the patients, all members providing care will respond to the following question in relation to specific treatment groups: '...I have been able to address the patient's problems yes/no..'
Measured: Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 May 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Alexandra Hospital, Brisbane, Australia, Macquarie University, Australia
- Responsible party
- Sponsor
- Investigators
- Gerald Holtmann, MD PhD, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274854
- Sponsor's protocol ID
- APP2004495
- Status last verified
- Sep 2024
- First submitted
- 7 Feb 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified group data will be analysed and published in medical journals
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms: A Randomised, Controlled Intervention to Assess Efficacy and Cost-effectiveness
- ClinicalTrials.gov ID
- NCT05274854
- Acronym / sponsor ID
- APP2004495
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Princess Alexandra Hospital, Brisbane, Australia, Macquarie University, Australia
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 for patients with relevant, chronic, or relapsing gastrointestinal symptoms without concerning features and on the wait list for integrated care clinic at the Princess Alexandra Hospital. Approximately 200 patients will initially receive standardised assessment of symptoms and wheat intolerance. Those patients that 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) an integrated care clinic conditional on their response to the initial intervention. Specific aims of the study include Aim 1: Determine efficacy (symptom improvement) and cost-effectiveness (quality adjusted life years) of a structured, digital technology enabled approach for the management of patients with severe functional gastrointestinal disorders as compared to established service models; Aim 2: Identify response-predictors for the pre-clinical dietary intervention, internet delivered cognitive behavior therapy, exercise physiology and the various clinical interventions; Aim 3: Define acceptance of consumers and staff for the new service model relative to established models of care and Aim 4. To determine the dietary patterns of people with functional gastrointestinal disorders who are presenting with symptoms necessary to access tertiary care and to further examine changes in diet after a range of interventions delivered by telehealth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Preconsultation Intervention | Experimental | Behavioral: a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothingPre-consultation intervention includes 4 arms ((a) standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing) |
| Consultation Intervention | Experimental | Behavioral: a) consultant-led outpatient clinic or b) a integrated care clinicConsultation intervention includes 2 arms (a) consultant-led outpatient clinic or b) a integrated care clinic depending on their response to the initial preconsultation intervention. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothingPre 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 | Behavioural | Preconsultation Intervention |
| a) consultant-led outpatient clinic or b) a integrated care clinicConsultation intervention consists of one of two interventions a) consultant-led outpatient clinic or b) a integrated care clinic | Behavioural | Consultation Intervention |
Primary outcome
Structured Assessment of Gastrointestinal Symptoms score
Time frame: Week 0
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
Structured Assessment of Gastrointestinal Symptoms score
Time frame: Week 8
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
Structured Assessment of Gastrointestinal Symptoms score
Time frame: Week 16
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
Structured Assessment of Gastrointestinal Symptoms score
Time frame: Week 20
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
Structured Assessment of Gastrointestinal Symptoms score
Time frame: Week 24
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
Structured Assessment of Gastrointestinal Symptoms score
Time frame: Week 28
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
Structured Assessment of Gastrointestinal Symptoms score
Time frame: Week 32
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
Structured Assessment of Gastrointestinal Symptoms score
Time frame: Week 35
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
Structured Assessment of Gastrointestinal Symptoms score
Time frame: Week 38
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
Structured Assessment of Gastrointestinal Symptoms score
Time frame: Week 44
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
European Quality of Life Five Dimension (EQ-5D)
Time frame: Week 0
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
European Quality of Life Five Dimension (EQ-5D)
Time frame: Week 8
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
European Quality of Life Five Dimension (EQ-5D)
Time frame: Week 16
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
European Quality of Life Five Dimension (EQ-5D)
Time frame: Week 20
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
European Quality of Life Five Dimension (EQ-5D)
Time frame: Week 24
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
European Quality of Life Five Dimension (EQ-5D)
Time frame: Week 28
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
European Quality of Life Five Dimension (EQ-5D)
Time frame: Week 32
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
European Quality of Life Five Dimension (EQ-5D)
Time frame: Week 35
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
European Quality of Life Five Dimension (EQ-5D)
Time frame: Week 38
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
European Quality of Life Five Dimension (EQ-5D)
Time frame: Week 44
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
Cost effectiveness
Time frame: Week 0
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)
Cost effectiveness
Time frame: Week 8
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)
Cost effectiveness
Time frame: Week 16
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)
Cost effectiveness
Time frame: Week 28
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)
Cost effectiveness
Time frame: Week 44
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)
10 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: Week 0
Hospital Anxiety and Depression Scale
Time frame: Week 16
Hospital Anxiety and Depression Scale
Time frame: Week 28
Hospital Anxiety and Depression Scale
Time frame: Week 44
Microbiome
Time frame: Week 0
Microbiome
Time frame: Week 16
Microbiome
Time frame: Week 28
Microbiome
Time frame: Week 44
Acceptance of models of care by consumers and staff
Time frame: Week 16
Acceptance of models of care by consumers and staff
Time frame: Week 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No. Deidentified group data will be analysed and published in medical journals
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RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 1
A Study to Investigate the Safety and Tolerability of Multiple Study Interventions in Participants With Moderate to Severe Ulcerative Colitis
Colitis, Ulcerative
RecruitingObservational study
Evaluation of Patients With Gastrointestinal Disease
Lower GI Disease, Gastrointestinal Diseases
RecruitingPhase 2
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor
Active, not recruitingPhase 3
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
Fecal Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Holtmann, MD PhD principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing and a) consultant-led outpatient clinic or b) a integrated care clinic in people with Gastrointestinal Diseases and Irritable Bowel Syndrome, run by The University of Queensland at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerald Holtmann, MD, PhD (61 7 3176 7792, g.holtmann@uq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured Assessment of Gastrointestinal Symptoms score (time frame: Week 0). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024; AzTrials last refreshed its copy on 2 Nov 2026.