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NCT Number: NCT01045837

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

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

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone and Gluten free diet

Drug

Gluten free diet and Oral Prednisolone in a dose of 1 mg/ kg will be given for a period of 4 weeks, thereafter Gluten free diet alone will be continued

Other names: Steroids, Wysolone

Gluten Free Diet

Behavioral

Only gluten free diet will be given in this group

Other names: Gluten

Primary outcomes

  1. Proportion of patients having improvement in symptoms at 4 weeks

    Time frame: 4 weeks

  2. Proportion of patients having improvement in histological improvement by at least one grade at 4 weeks

    Time frame: 4 weeks

Secondary outcomes

  1. Proportion of patients showing normalization of histological abnormalities at 6 months

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

Effect of Addition of Short Course of Prednisolone to Gluten Free Diet and Gluten Free Diet Alone in the Recovery of Clinical, Histological and Immunological Features in Naive Adult Patients With Celiac Disease

Acronym: CD

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 11, 2010
Registry last updated
Jan 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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