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Cytokine Profile in Children With Celiac Disease

NCT02244047 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2014-09-18

No results posted yet for this study

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

Conditions

Interventions

DRUG

Bifidobacterium breve

DRUG

Placebo (for Bifidobacterium breve)

Sponsors & Collaborators

  • Slovenian Research Agency

    collaborator OTHER

  • University Medical Centre Maribor

    lead OTHER

Principal Investigators

  • Martina Klemenak, md · University Medical Centre Maribor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-06-30
Completion
2014-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02244047 on ClinicalTrials.gov