Safety of a new variety of barley for participants with coeliac disease
- Conditions
- coeliac diseaseOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12618000393257
- Lead Sponsor
- CSIRO Health and Biosecurity
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 62
•Medically diagnosed coeliac disease (CD)
•Have followed a GF diet for at least 2 years confirmed by history and normal CD serology (see exclusion criteria for normal range) from sample collected at screening visit
•Males and females aged 18-75 years
•No history of illness for the past 4 weeks which will affect their fitness for endoscopy, and any diarrhoeal illness
•Understand the study and agree to participate
•Are prepared to adhere to gluten free diet for the 12 weeks of the run-in and study
•Able to attend FMC (or Noarlunga Hospital) on 4 occasions during the study
•Prepared to undergo 2 endoscopies
•Willing to consume one serve of about 60g of investigational product daily for 8 weeks
• Refractory coeliac disease (CD), severe CD complications (eg enteropathy associated T-cell lymphoma or active dermatitis herpetiformis lesions at the time of screening)
• Screening CD antibody serology results outside normal range: participants excluded if deamidated gliadin IgG (AGA) is >11 units/mL or if anti-tissue transglutaminase antibody (tTG-IgA) is >11 units/mL
• Other chronic inflammatory or functional gastrointestinal disease (eg symptomatic gastrointestinal reflux disease, inflammatory bowel disease, functional bowel disorders)
• Uncontrolled diabetes or autoimmune, psychiatric, neurological disease or chronic disease (eg HIV-AIDS or cancer other than skin cancer) that could interfere with assessments
• Extended absences due to travel or other commitments
• Reported lactating, pregnant or wish to become during the study. If a participant becomes pregnant during the trial they will be withdrawn
• Other than oral contraceptives use of other medications or over-the-counter supplements that in the opinion of the gastroenterologist may interfere with study outcomes, including antibiotics, non-steroidal anti-inflammatory drugs, medications that alter microbiota function for 2 months prior to and during the clinical intervention. Stable regular dose of non-steroidal anti-inflammatory drugs that were commenced prior to screening visit are allowed with approval of the Principal Investigator.
• Use of any immunosuppressive medications for 6 months prior to and during the clinical intervention
• Use of warfarin or enoxaparin. Use of direct oral anticoagulants like xarelto, apixaban, rivoraxaban and antiplatelet medications like clopidogrel, prasugrel and ticagrelor. Use of aspirin is allowed
• Received any experimental drug within 14 days of randomisation; in the case of biologics at least 6 months prior to randomisation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method