CTRI/2009/091/000346CompletedPhase 2
Effect of trace amounts of dietary gluten on nutritional, clinical, serological, biochemical and histological parameters of pediatric patients with celiac disease.
Indian Council of Medical Research ICMR New Delhi0 sites30 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Screening I (Atleast one month before baseline):
- •The subjects recruited for the study were biopsy and serology-proven celiac disease patients who were 7 to 12 yrs of age (either sex), and compliant on gluten-free diet for atleast 1 year.
- •The confirmed CD patients who satisfy the following criteria were included:
- •a)7 to 12 yrs of age.
- •b)Either sex.
- •c)Confirmed CD patients on gluten-free diet for at least 1year - By following a standard GFD compliance protocol.
- •d)CD patients who gave consent and were able to follow-up for the microchallenge.
- •Screening II (At Baseline)
- •Those patients were recruited for microchallenge who were Anti-EMA negative, showed improvement in Histology (Marsh criteria) from:
- •Severe to either moderate or mild villus atrophy or normal
- •Moderate to mild villus atrophy or normal
- •Mild villus atrophy to normal
Exclusion Criteria
- •The following patients were excluded:
- •a)Poorly compliant on GFD.
- •b)Those having other autoimmune diseases.
Investigators
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