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This is a sequential study to evaluate the effect of parabiotics as an adjuvant therapy with gluten restriction on quality of life in children with Celiac disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric celiac patients | Experimental | Strict gluten free food regimen for 3 weeks then parabiotics (Lacteolfort ®) added for another 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeks | Other | Gluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of parabiotics as an adjuvant on celiac patients' quality of life . | Evaluate the effect of parabiotics as an adjuvant therapy to gluten free diet in celiac patients' quality of life using pediatric quality of life(PedsQL)Gastrointestinal symptoms module version 3.0. It has specific gastrointestinal symptom domains, scoring from 0-4 (0 indicates never a problem, 1 indicates almost never a problem, 2 indicates sometimes a problem, 3 indicates often a problem and 4 indicates almost always a problem) then cores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The higher the score is the better quality of life, there is no cutoff value for this score. | 3 weeks |
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Inclusion Criteria:
• Celiac cases diagnosed either by non-biopsy approach {serology based: high IgA antibodies against transglutaminase ≥10 times the upper limit of normal with positive endomysial antibodies or diagnosed by biopsy using March classification
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Abbassia | 1181 | Egypt |
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| ID | Term |
|---|---|
| D055050 | Diet, Gluten-Free |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |