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| Name | Class |
|---|---|
| Slovenian Research Agency | OTHER |
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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
In the investigators research will be selected 70 children, age from 2 to 18 years, divided in different groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bifidobacterium breve | Active Comparator | Bifidobacterium breve BR03 and B632 powder containing 10/9 CFU daily dosage in a period of 3 months |
|
| Placebo | Active Comparator | Placebo in the same powder packages as Bifidobacterium breve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifidobacterium breve | Drug |
| ||
| Placebo (for Bifidobacterium breve) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum TNF-alpha decrease after Bifidobacterium breve daily consumption in children with celiac disease | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martina Klemenak, md | University Medical Centre Maribor | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26134988 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 25, 2016 | |
| Reset | Dec 16, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 25, 2016 | Dec 16, 2016 |
| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Drug |
|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |