A clinical trial to study the effects of very minute quantity of wheat in the pediatric patients with celiac disease.
- Conditions
- Health Condition 1: null- Celiac Disease
- Registration Number
- CTRI/2009/091/000346
- Lead Sponsor
- Indian Council of Medical Research ICMR New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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
OR
Moderate to mild villus atrophy or normal
OR
Mild villus atrophy to normal
The following patients were excluded:
a)Poorly compliant on GFD.
b)Those having other autoimmune diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method C : V (Crypt depth / Villus height) ratioTimepoint: At baseline and end of three months intervention
- Secondary Outcome Measures
Name Time Method IEL (Intraepithelial lymphocyte) count, Surface Epithelial Cell height, lamina propria infiltration, Serological, nutritional,clinical, biochemical parametersTimepoint: At baseline and at end of three months intervention.