Health Condition 1: null- Celiac Disease
Conditions
Interventions
Intervention1: Gluten present in wheat: 0 mg, 30 mg and 50 mg of gluten/day (present in wheat) given in form of wheat capsules for three months (in six equally divided doses per day), to the subjects
Sponsors
Indian Council of Medical Research ICMR New Delhi
Eligibility
Inclusion 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 OR Moderate to mild villus atrophy or normal OR Mild villus atrophy to normal
Exclusion criteria
Exclusion criteria: The following patients were excluded: a) Poorly compliant on GFD. b) Those having other autoimmune diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C : V (Crypt depth / Villus height) ratioTimepoint: At baseline and end of three months intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
India
Contacts
Public ContactShikha Nayar
All India Institute of Medical Sciences
Outcome results
None listed