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Effect of Addition of Short Course of Prednisolone to Gluten Free Diet in Naive Celiac Disease Patients (CD)

A

All India Institute Of Medical Science (AIIMS)

Status and phase

Completed
Phase 3
Phase 2

Conditions

Celiac Disease

Treatments

Behavioral: Gluten free diet
Drug: Prednisolone and Gluten free diet

Study type

Interventional

Funder types

Other

Identifiers

NCT01045837
Celiac-Prednisolone

Details and patient eligibility

About

Withdrawal of gluten, the culprit antigen, is the definite treatment for celiac disease. Weeks to months after gluten withdrawal from the diet before the clinical manifestations, histological features start improving. Many of the adult patients are in the critical phase where even weeks may matter especially those in their adolescence where height growth has limited potential.

Suppression of immune system using a short course of steroid might retard the immune mediated destruction of the villi while the effect of gluten withdrawal sets in. Steroids are known to be effective in the management of refractory celiac disease. Therefore, the investigators hypothesized that addition of a short course of steroid to gluten free diet may enhance intestinal mucosal recovery and thus clinical manifestations

Full description

Celiac disease is a chronic systemic autoimmune disorder induced by gluten proteins present in wheat, barley, and rye. Steroids affect proliferative responses of both B and T cells in vitro, and the production of lymphokines (migratory inhibitory factor) by cultured cells. Steroids inhibit the effect of gluten proteins through their action on elements of the immune system. Glucocorticoids are reserved for severely ill patients, who present with celiac crisis, gliadin shock, and refractory sprue. We hypothesized that addition of a short course of steroid to gluten free diet may enhance intestinal mucosal recovery and thus clinical manifestations.

Enrollment

33 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Naïve patients with celiac disease (CD will be diagnosed as per revised European Society of Pediatric Gastroenterology and Nutrition criteria
  • Both sexes
  • Age>12 years

Exclusion criteria

  • Partially treated celiac disease
  • Co-existent systemic diseases
  • HIV seropositive
  • Seropositive with HBsAg , Anti HCV Ab
  • Past H/O tuberculosis
  • Evidence of active tuberculosis
  • Unwilling patient

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

33 participants in 2 patient groups, including a placebo group

Prednisolone and Gluten free diet
Active Comparator group
Description:
Gluten free diet and prednisolone in the dose of 1 mg/kg/d over a period of 4 weeks.
Treatment:
Drug: Prednisolone and Gluten free diet
Gluten free diet
Placebo Comparator group
Description:
Gluten free alone will be given in this group
Treatment:
Behavioral: Gluten free diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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