This study seeks to find out if addition of a short course of steroids in addition to gluten free diet is safe and more effective than gluten free diet alone to treat Celiac disease.

Efficacy and safety of addition of short course of prednisolone to gluten free diet (GFD) versus gluten free diet alone in the clinical, immunological and histological recovery of celiac disease.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/08/009517

Enrollment

Registered

2017-08-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Celiac Disease

Interventions

Intervention1: prednisolone in addition to Gluten free diet: 1 mg/kg for 1 month Control Intervention1: Gluten Free Diet alone: life long

Eligibility

Inclusion criteria

Inclusion criteria: -New cases of Celiac Disease -Both sexes -Age: 1-18 years

Exclusion criteria

Exclusion criteria: 1. Partially treated celiac disease 2. Coexistent systemic disease 3. HIV seropositive or HBs Ag positive 4. Past H/O tuberculosis or evidence of active tuberculosis 5. Unwillling patients / parents

Design outcomes

Primary

Measure	Time frame
-Proportion of patients having improvement in symptoms at 4 weeks of GFD. -Proportion of patients having improvement in histology by at least one grade and sero-negative at 8 weeks of GFD. Timepoint: 8 weeks;-Proportion of patients having improvement in symptoms at 4 weeks of GFD. -Proportion of patients having improvement in histology by at least one grade and sero-negative at 8 weeks of GFD. Timepoint: 8 weeks;-Proportion of patients having improvement in symptoms at 4 weeks of GFD. -Proportion of patients having improvement in histology by at least one grade and sero-negative at 8 weeks of GFD. Timepoint: 8 weeks;-Proportion of patients having improvement in symptoms at 4 weeks of GFD. -Proportion of patients having improvement in histology by at least one grade and sero-negative at 8 weeks of GFD. Timepoint: 8 weeks;-Proportion of patients having improvement in symptoms at 4 weeks of GFD. -Proportion of patients having improvement in histology by at least one grade and sero-negative at 8 weeks of GFD. Timepoint: 8 weeks	—

Measure

Time frame

-Proportion of patients having improvement in symptoms at 4 weeks of GFD. -Proportion of patients having improvement in histology by at least one grade and sero-negative at 8 weeks of GFD. Timepoint: 8 weeks;-Proportion of patients having improvement in symptoms at 4 weeks of GFD. -Proportion of patients having improvement in histology by at least one grade and sero-negative at 8 weeks of GFD. Timepoint: 8 weeks;-Proportion of patients having improvement in symptoms at 4 weeks of GFD. -Proportion of patients having improvement in histology by at least one grade and sero-negative at 8 weeks of GFD. Timepoint: 8 weeks;-Proportion of patients having improvement in symptoms at 4 weeks of GFD. -Proportion of patients having improvement in histology by at least one grade and sero-negative at 8 weeks of GFD. Timepoint: 8 weeks;-Proportion of patients having improvement in symptoms at 4 weeks of GFD. -Proportion of patients having improvement in histology by at least one grade and sero-negative at 8 weeks of GFD. Timepoint: 8 weeks

—

Secondary

Measure	Time frame
-Proportion of patients showing normalization of histological features and sero-negative at 6 months and 1 year of GFD.Timepoint: 12 months	—

Countries

India

Contacts

Public ContactProf Tabassum Shahab

Department of Pediatrics, Jawaharlal Nehru Medical College, ALigarh Muslim University

seema_alam@hotmail.com09761078843

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026