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NCT02244047 Clinical Trial

Cytokine Profile in Children With Celiac Disease

Celiac Disease Clinical Trial

Official title:
Exploratory, Placebo-controlled Study on the Effects of Bifidobacterium Breve in Children With Celiac Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02244047
Other study ID # CEL-BIF
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 16, 2014
Last updated September 17, 2014
Start date October 2013
Est. completion date June 2014

Study information
Verified date September 2014
Source University Clinical Centre, Maribor
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 18 Years
Eligibility Inclusion Criteria:

- celiac disease on gluten free diet

Exclusion Criteria:

- acute or chronic diseases,

- permanent use of medication and

- ingestion of antibiotics at least one month prior to study

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bifidobacterium breve

• Placebo (for Bifidobacterium breve)

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University Clinical Centre, Maribor Slovenian Research Agency

Outcome
Type Measure Description Time frame Safety issue
Primary Serum TNF-alpha decrease after Bifidobacterium breve daily consumption in children with celiac disease 3 months
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