Single-Site,Single Blind, Placebo-Controlled Study of Gluten Digesting Enzymes as Modulators of Gluten Intolerance Symptoms.
Not Applicable
- Conditions
- Gluten intolerance
- Registration Number
- JPRN-UMIN000028295
- Lead Sponsor
- Amano Enzyme Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1.Subjects with a diagnosis of celiac disease proven by a biopsy 2.Subjects with uncontrolled chronic health conditions such as Type I and Type II diabetes, cardiovascular disease, etc. 3. Women who are pregnant, intending to become pregnant during the study period or currently lactating. 4. Subjects with certain combinations of serum antibodies indicating the possibility of celiac disease (strongly positive for both anti-transglutaminase and anti-gliadin antibodies; see Appendix 4).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Analysis of gluten intolerance symptoms after 2 weeks
- Secondary Outcome Measures
Name Time Method 1.Safety 2.Biomarkers(RANTES,TNF-alpha,IL-8) 3.Gluten intolerance symptoms(Questionnaire)