NCT Number: NCT02244047
Cytokine Profile 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
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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Notify MeKey information
Conditions
Age range
1 year–18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo (for Bifidobacterium breve)
DrugPrimary outcomes
-
Serum TNF-alpha decrease after Bifidobacterium breve daily consumption in children with celiac disease
Time frame: 3 months
Sponsors and collaborators
Lead sponsor
University Medical Centre Maribor
Other
Collaborators
- Slovenian Research Agency
Registry information
Official study title
Exploratory, Placebo-controlled Study on the Effects of Bifidobacterium Breve in Children With Celiac Disease
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Sep 18, 2014
- Registry last updated
- Sep 18, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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