An initiative to find a new treatment to Celiac disease.

Phase 2

Completed

• Conditions: Health Condition 1: null- Celiac disease in remission

• Registration Number: CTRI/2018/03/012624
• Lead Sponsor: Dr Ajit Sood

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-08-31
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

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.

�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

•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

Study & Design

• Study Type: Interventional
• Study Design: Not specified