A pilot study on the celiac support capsule in patients suffering from celiac disease
Phase 2
- Conditions
- Celiac.Intestinal malabsorption
- Registration Number
- IRCT20180103038199N17
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Having celiac disease
Age between 5 to 30 years
Not suffering from other diseases
Normal liver and kidney status
Not pregnant
Exclusion Criteria
The occurrence of drug allergy
Occurrence of clinical symptoms of celiac disease within 48 hours
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical symptoms such as diarrhea, urticaria, abdominal pain and bloating, nausea, vomiting, dyspepsia, abdominal pain, headache, fatigue, skin rashes. Timepoint: Weekly. Method of measurement: Checklist.
- Secondary Outcome Measures
Name Time Method Anti-transglutaminase antibody. Timepoint: At the beginning of the study and after 3 months of treatment. Method of measurement: Laboratory kit.;Antiendomysial antibody. Timepoint: At the beginning of the study and after 3 months of treatment. Method of measurement: Laboratory kit.;Anti-gliadin antibody (AGA). Timepoint: At the beginning of the study and after 3 months of treatment. Method of measurement: Laboratory kit.;Intraepithelial lymphocytes (IEL). Timepoint: At the beginning of the study and after 3 months of treatment. Method of measurement: Laboratory kit.