Cytokine Profile in Children With Celiac Disease

Status Completed

Clinical Trial Summary

Celiac disease (CD) is an immune-mediated systemic disease that is elicited by consumption of gluten and related prolamines in genetically susceptible individuals. Not only genetic but also environmental factors play an important role in CD pathogenesis. CD patients have imbalance in the gut microbiota, they have reduced number of Bididobacterium species in feces and biopsies.

Up till now, only effective treatment for CD is life long adherence to gluten free diet. If gluten free diet is not strict that leads over the years to complications of disease, such as autoimmune diseases, psychiatric diseases, osteoporosis etc. That may be caused by continuous recirculation of activated immune cells between the inflamed organ and the periphery. To avoid complications of disease in long term the investigators want to test specific probiotic bacteria from Bifidobacteria genus, that has has been in vitro studies recognized as anti-inflammatory.

Hypothesis

1. Children with celiac disease on gluten free diet have a higher level of pro-inflammatory cytokine (TNF-alpha) and anti-inflammatory cytokine (IL-10) in comparison with healthy controls.

2. 3 months after daily probiotic consumption TNF-alpha level decrease and IL-10 level increase.

In the investigators research will be selected 70 children, age from 2 to 18 years, divided in different groups:

1. Group: 25 children with celiac disease on GFD for at least 3 months and will receive probiotic for 3 months.

2. Group: 25 children with celiac disease on GFD for at least 3 months and will receive placebo for 3 months.

3. Group: 20 healthy children

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Celiac Disease

Clinical Trial Details

NCT number	NCT02244047
Study type	Interventional
Source	University Clinical Centre, Maribor
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	October 2013
Completion date	June 2014

View Details

See also
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	`NCT02312349` - Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City
Completed	`NCT02472704` - Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo	N/A
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