- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02244047
Cytokine Profile in Children With Celiac Disease
Exploratory, Placebo-controlled Study on the Effects of Bifidobacterium Breve in Children With Celiac Disease
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
- 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.
- 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:
- Group: 25 children with celiac disease on GFD for at least 3 months and will receive probiotic for 3 months.
- Group: 25 children with celiac disease on GFD for at least 3 months and will receive placebo for 3 months.
- Group: 20 healthy children
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bifidobacterium breve
Bifidobacterium breve BR03 and B632 powder containing 10/9 CFU daily dosage in a period of 3 months
|
|
Active Comparator: Placebo
Placebo in the same powder packages as Bifidobacterium breve
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum TNF-alpha decrease after Bifidobacterium breve daily consumption in children with celiac disease
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Martina Klemenak, md, University Medical Centre Maribor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEL-BIF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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