Celiac Disease Clinical Trial
Official 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
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
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04349904 -
Near-Focus NBI Classification of Villous Atrophy in Suspected Coeliac Disease: International Development and Validation
|
||
Recruiting |
NCT05581628 -
FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
|
||
Completed |
NCT04593251 -
Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis
|
Phase 1 | |
Completed |
NCT05810441 -
Intestinal Transglutaminase Antibodies in Celiac Disease Diagnosis
|
||
Recruiting |
NCT05555446 -
Bovine Colostrum to Prevent Absorption of Gluten
|
Early Phase 1 | |
Completed |
NCT02754609 -
Hookworm Therapy for Coeliac Disease
|
Phase 1 | |
Terminated |
NCT01902368 -
Celiac Disease Screening
|
N/A | |
Completed |
NCT02472704 -
Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo
|
N/A | |
Completed |
NCT02312349 -
Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City
|
||
Completed |
NCT01172665 -
Celiac Disease Database
|
||
Completed |
NCT01100099 -
HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease
|
Phase 2/Phase 3 | |
Completed |
NCT00639444 -
Risk of Celiac Disease and Age at Gluten Introduction
|
N/A | |
Active, not recruiting |
NCT05425446 -
Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
|
Phase 1 | |
Enrolling by invitation |
NCT02202681 -
Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule
|
N/A | |
Completed |
NCT00362856 -
Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects
|
Phase 2 | |
Terminated |
NCT03866538 -
Budesonide in Patients With Immune Mediated Enteropathies
|
Phase 4 | |
Recruiting |
NCT05135923 -
Glutenfree, Gut Microbiota and Metabolic Regulation
|
N/A | |
Completed |
NCT05052164 -
Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women
|
N/A | |
Completed |
NCT03775499 -
Probiotic BL NCC 2705 and Gluten Sensitivity
|
N/A | |
Completed |
NCT03707730 -
A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease
|
Phase 2 |