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Trial registered on ANZCTR


Registration number
ACTRN12620000259943
Ethics application status
Approved
Date submitted
10/02/2020
Date registered
27/02/2020
Date last updated
27/02/2020
Date data sharing statement initially provided
27/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
How well do tests that measure gluten in the faeces detect low-level dietary gluten exposure in people with coeliac disease?
Scientific title
Assessing the performance of gluten immunogenic peptide (GIP) faecal assays after double-blind, single-dose gluten or placebo challenge in adults with treated coeliac disease
Secondary ID [1] 300445 0
None
Universal Trial Number (UTN)
U1111-1247-7658
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coeliac Disease 316177 0
Autoimmune 316178 0
Condition category
Condition code
Inflammatory and Immune System 314470 314470 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised, double-blind food challenge study. Adult participants with treated coeliac disease be randomised to consume a single gluten-free cookie (the intervention) containing vital wheat gluten (one of 4 set doses, from 50 mg up to 1 g gluten) or placebo (0 mg gluten). The cookie will be prepared by a designated unblinded clinical research nurse who will not have contact with the participant. A separate clinical research nurse will provide the cookie to the participant and it will be consumed at their home. Collection of faecal samples will commence two weeks prior to the challenge (3 times per week) and, after the challenge, each stool passed will be collected for at least one week or until at least 3 samples are obtained if more than one week is required. The faecal samples will be stored frozen for later analysis using a gluten immunogenic peptide (GIP) faecal assay (ivyLISA). The challenge and monitoring will be conducted in the participant’s own home/work environment.
Intervention code [1] 316804 0
Treatment: Devices
Comparator / control treatment
The placebo gluten-free cookie will contain 1 g gluten-free rice flour.
Control group
Placebo

Outcomes
Primary outcome [1] 322800 0
Proportion of patients with positive faecal GIP (mcg/g stool; iVYLISA assay) in any stool passed after intervention.
Timepoint [1] 322800 0
All stools passed within 7 days after the intervention
Secondary outcome [1] 379828 0
Onset of positive faecal GIP (mcg/g stool; iVYLISA assay) after intervention
Timepoint [1] 379828 0
All stools passed within 7 days after the intervention
Secondary outcome [2] 379829 0
Change in symptomatology (Gastrointestinal Symptom Rating Score, and the CeD PRO Measure) from baseline to after the intervention
Timepoint [2] 379829 0
Daily commencing 2 weeks prior until 1 week after intervention
Secondary outcome [3] 379830 0
Change in coeliac disease serology (transglutaminase-IgA) from baseline to after the intervention
Timepoint [3] 379830 0
Study commencement and 1 month after intervention
Secondary outcome [4] 379831 0
Correlation between faecal GIP as measured by iVYLISA assay and At-home kit
Timepoint [4] 379831 0
Select faecal samples that are negative and positive for GIP from the week after the intervention
Secondary outcome [5] 380309 0
Duration of positive faecal GIP (mcg/g stool; iVYLISA assay) after intervention
Timepoint [5] 380309 0
All stools passed within 7 days after the intervention
Secondary outcome [6] 380311 0
Change in coeliac disease serology (deamidated gliadin peptide-IgG) from baseline to after the intervention
Timepoint [6] 380311 0
Study commencement and 1 month after intervention

Eligibility
Key inclusion criteria
Adults 18 up to 70 years of age including males and females.
A diagnosis of coeliac disease based on consensus criteria (positive coeliac serology and typical small intestinal enteropathy at diagnosis), and following a strict gluten free diet for at least 12 months with negative coeliac serology and normal Celiac Dietary Adherence Test (CDAT) at baseline.
Faecal samples from coeliac or non-coeliac (healthy) participants not following a gluten free diet will also be collected and serve as positive controls for the faecal assay.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent, understand English, or suffering from a medical condition that the investigator believes may affect the safe conduct of the trial or complicate interpretation of results.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed through the use of numbered gluten challenge packs set up by team member who has not direct contact with participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
pharmacokinetics (time course of gluten appearance in faeces)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15827 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 29271 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 304861 0
University
Name [1] 304861 0
University of Melbourne - Centenary Fellowship and The Walter and Eliza Hall Institute - Coeliac Lab research Funds
Address [1] 304861 0
Individual
A/Professor Jason Tye-Din
The Walter and Eliza Hall Institute
1G Royal Parade
Parkville VIC 3052
Country [1] 304861 0
Australia
Primary sponsor type
Individual
Name
A/Professor Jason Tye-Din
Address
The Walter and Eliza Hall Institute
1G Royal Parade
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 305200 0
None
Name [1] 305200 0
Address [1] 305200 0
Country [1] 305200 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305272 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 305272 0
Royal Melbourne Hospital
300 Gratten St
Parkville VIC 3050
Ethics committee country [1] 305272 0
Australia
Date submitted for ethics approval [1] 305272 0
Approval date [1] 305272 0
27/11/2003
Ethics approval number [1] 305272 0
MH HREC 2003.009

Summary
Brief summary
Achieving optimal health for people with CD requires a strict gluten free diet. Unfortunately, accidental gluten intake is common. Assessing for gluten intake based on dietitian evaluation or coeliac serology lacks sensitivity and small intestinal histology requires an invasive test. This study will assess a new test that measures gluten (gluten immunogenic peptides) in a faecal (stool) sample. Participants will consume a gluten-free cookie containing either a small amount of gluten (equivalent to a “real-world” contamination) or placebo and their faeces assessed. The study will inform how this objective test can be deployed in clinical practice to support people following a strict gluten free diet.
Trial website
Trial related presentations / publications
Public notes
The ethics approval covers a long-standing and ongoing suite of studies aiming to understand gluten immunity in coeliac disease. The approval enables people with coeliac disease to consume gluten orally and be monitored before and after with blood and faecal testing. The ethics approval to include testing of faeces for gluten content by GIP assay was 03/10/2019.

Contacts
Principal investigator
Name 99838 0
A/Prof Jason Tye-Din
Address 99838 0
The Walter and Eliza Hall Institute
1G Royal Parade
Parkville 3052 VIC

Country 99838 0
Australia
Phone 99838 0
+61 3 9345 2533
Fax 99838 0
Email 99838 0
Coeliac@wehi.edu.au
Contact person for public queries
Name 99839 0
A/Prof Jason Tye-Din
Address 99839 0
The Walter and Eliza Hall Institute
1G Royal Parade
Parkville 3052 VIC

Country 99839 0
Australia
Phone 99839 0
+61 3 9345 2533
Fax 99839 0
Email 99839 0
Coeliac@wehi.edu.au
Contact person for scientific queries
Name 99840 0
A/Prof Jason Tye-Din
Address 99840 0
The Walter and Eliza Hall Institute
1G Royal Parade
Parkville 3052 VIC

Country 99840 0
Australia
Phone 99840 0
+61 3 9345 2533
Fax 99840 0
Email 99840 0
Coeliac@wehi.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results