nderstanding how gluten causes symptoms in coeliac disease (CD)and non-coeliac gluten sensitivity (NCGS)

Not Applicable

• Conditions: Coeliac Disease; Non-Coeliac Gluten Sensitivity; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Inflammatory and Immune System - Other inflammatory or immune system disorders; Inflammatory and Immune System - Autoimmune diseases

• Registration Number: ACTRN12624000708550
• Lead Sponsor: Walter and Eliza Hall Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-06
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Adults 18 to 75 years of age (inclusive) who have signed an informed consent form.
2. The coeliac cohort will have CD diagnosed on the basis of duodenal biopsies showing villous atrophy and abnormal CD-specific serology
3. The NCGS cohort will have CD excluded on the basis of duodenal biopsies showing no villous atrophy and/or normal CD-specific serology whilst eating gluten, or negative HLA susceptibility for CD
4. The unaffected (healthy) controls will have normal CD-specific serology whilst eating gluten and no reported gluten-specific symptoms.
5. Have followed a GFD prior to participation for the required length of time
6. Willingness to consume up to 6 grams of vital wheat gluten
7. Willingness to undergo study procedures.
8. Able to read and understand English

Exclusion Criteria

1. Intentional consumption of gluten-containing food within the previous one month in the CD and NCGS groups.
2. Any medical condition or an immune-suppressing medical treatment taken within the previous 3 months that in the opinion of the investigator would impact the immune response (other than CD), confound interpretation of study results, or pose an increased risk to the patient. Topical or inhaled corticosteroids are acceptable.
3. Females who are pregnant, including those with positive urinary pregnancy test on the first day of screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak circulating serotonin (5-HT)[Change in serum 5-HT level following gluten challenge compared to baseline Baseline, plus 2, 4 and 6 hours post-challenge]

Secondary Outcome Measures

Name	Time	Method
Duodenal tissue IL-2 gene expression[Change in IL-2 mRNA expression after ingestion of gluten compared to placebo From duodenal biopsy tissue collected 4 hours post-gluten or -placebo challenge];Symptoms will be measured as a composite outcome using a modified Coeliac Disease Patient Reported Outcome measure (CeD PRO) that will include assessment of abdominal cramping/pain, bloating, constipation, diarrhoea, gas, loose stools, nausea, vomiting, headaches and tiredness.[Assessment is based on the CeD PRO questionnaire modified to include vomiting and record and quantify symptoms hourly following gluten or placebo challenge. The CeD-PRO was designed for coeliac disease-specific symptom assessment in clinical trial (https://doi.org/10.1053/j.gastro.2015.02.008). Within one hour before gluten/placebo challenge and again hourly up to 6 hours post-challenge.]