Health Condition 1: null- Celiac disease in remission
Conditions
Interventions
Intervention1: Gluten protein extracted from commercially available wheat.: The dose of gluten protein will be increased slowly and gradually starting from 1 mg wheat flour (0.1 mg gluten protein) to
Sponsors
Dr Ajit Sood
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria (1) All the patients will be informed in detail about the purpose of the study and the patients willing to participate and give a written consent will be enrolled in for the study. (2) Patients to be taken for the study should be confirmed cases of celiac disease and on Gluten free diet (GFD) (diagnosis established according to the revised ESPGHAN criteria). (3) Eligibility criteria: This will include celiac disease diagnosis established by duodenal mucosal biopsy, attempted adherence to gluten free diet for >= 2 years and being in clinical, biochemical and histologic remission (i.e. tTG-IgA negative, normal vh/cd ratio and no gluten associated symptoms). ï?§ Clinical remission - Absence of any gluten associated symptoms known to occur in patients with celiac disease. ï?§ Biochemical remission- This will include normal anti-tTG value. In addition to this, various markers of gluten related injury will also be assessed: (IFN-γ, plasma citrulline, I-FABP). ï?§ Histological remission â?? Normal vh/cd ratio (i.e. 4:1). ï?§ Along with being in clinical, biochemical and histologic remission the eligibility will also include the following tests: anti-TTG, Complete blood count, IFN-γ, plasma citrulline, I-FABP, vh/cd ratio and IELâ??s (to set a baseline for these parameters). (4) Controls: These would be celiac patients in complete remission and on strict Gluten Free Diet.
Exclusion criteria
Exclusion criteria: • Any active symptoms of the disease • Contraindication to perform endoscopy and intestinal biopsy • Current untreated or active peptic ulcer disease, IBS or IBD • Co morbidity (uncontrolled chronic disease or condition -AIDS) • Type I DM • On immunosuppressive medications 6 months prior to entry • History of alcohol or illicit drug use within past 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To find a new treatment method for treating celiac disease patients.Timepoint: The serological parameters (anti TTG, anti EMA, CBC, plasma citrulline, I-FABP) will be assessed every month. Histological parameters will be assessed after 1 year or earlier if symptoms appear. | — |
Secondary
| Measure | Time frame |
|---|---|
| Can celaic disease patients tolerate lower doses of gluten protein.Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Ajit Sood
Dayanand Medical College and Hospital
Outcome results
None listed