ACTRN12618000393257
Recruiting
未知
A clinical study determining the safety and gut health benefits of a new variety of barley in participants with coeliac disease
CSIRO Health and Biosecurity0 sites62 target enrollmentMarch 16, 2018
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- coeliac disease
- Sponsor
- CSIRO Health and Biosecurity
- Enrollment
- 62
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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 If a participant becomes pregnant during the trial they will be withdrawn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
Outcomes
Primary Outcomes
Not specified
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