Celiac Disease in Children
Conditions
Brief summary
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.
Interventions
OTHERGluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeks
Gluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeks.
Sponsors
Ain Shams University
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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
* Immunocompromised patients * Patients taking immunosuppressant drugs or antibiotics within the last 4 weeks or during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effect of parabiotics as an adjuvant on celiac patients' quality of life . | 3 weeks | 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. |
Countries
Egypt
Outcome results
None listed