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Coeliac Disease Study Dunedin 103
Coeliac Disease Study
Dunedin
Please note that this study has now closed. However, we encourage you to pre-register your interest for future coeliac disease studies here.
Description
What to expect
Study details
Ages
18 to 70 years old
Duration
29-day treatment period
Compensation
Participants will be reimbursed for study visits and reasonable study-related travel expenses.
Eligibility Criteria
You may be eligible to take part if you:
- Are aged 18 to 70 years of age.
- Have a biopsy-proven diagnosis or positive blood tests for Coeliac Disease
- Experienced relief from symptoms and been on a Gluten free diet for at least 12 months.
- Are willing to eat up to 10 grams of wheat gluten powder (between 2 and 3 slices of bread) each day, for 3 consecutive days during the study.
- Are willing to record symptoms in the provided electronic diary for 29 days.
Locations
Description
Momentum Clinical Research is conducting a research study to test a new investigational treatment for people with diagnosed coeliac disease who have experienced relief from symptoms after being on a gluten free diet for at least 12 months.
What to expect
Participants will receive the study treatment or placebo and then consume 10g of gluten powder (about 2 -3 slices of bread) each day, for three days. We'll be looking at how well the investigational treatment is tolerated and if it reduces the immune response to gluten.
After being approved to join the study, participants will be randomly assigned to receive a single dose of the study drug or a placebo (a harmless substance). Nine days after receiving the study treatment or placebo, participants will be given a wheat gluten powder every day for three days – equivalent to approximately 2 to 3 slices of bread per day. After that, participants will visit the clinic regularly until the study ends, The treatment period is 29 days and follow-up period till 176 days.
This study is now closed
Please note that this study has now closed. However, we encourage you to pre-register your interest for future coeliac disease studies here.