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
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University Clinical Centre, Maribor University Medical Centre Maribor