Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
66 participants
INTERVENTIONAL
2013-10-31
2014-06-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Bifidobacterium breve
Bifidobacterium breve BR03 and B632 powder containing 10/9 CFU daily dosage in a period of 3 months
Bifidobacterium breve
Placebo
Placebo in the same powder packages as Bifidobacterium breve
Placebo (for Bifidobacterium breve)
Interventions
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Bifidobacterium breve
Placebo (for Bifidobacterium breve)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* permanent use of medication and
* ingestion of antibiotics at least one month prior to study
1 Year
18 Years
ALL
Yes
Sponsors
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Slovenian Research Agency
OTHER
University Medical Centre Maribor
OTHER
Responsible Party
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Martina Klemenak
medical doctor, resident at Pediatric department
Principal Investigators
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Martina Klemenak, md
Role: PRINCIPAL_INVESTIGATOR
University Medical Centre Maribor
References
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Klemenak M, Dolinsek J, Langerholc T, Di Gioia D, Micetic-Turk D. Administration of Bifidobacterium breve Decreases the Production of TNF-alpha in Children with Celiac Disease. Dig Dis Sci. 2015 Nov;60(11):3386-92. doi: 10.1007/s10620-015-3769-7. Epub 2015 Jul 2.
Other Identifiers
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CEL-BIF
Identifier Type: -
Identifier Source: org_study_id
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