Status:
COMPLETED
Effectiveness of PENTABIOCEL in Clinical and Laboratory Recovery of Children With Celiac Disease
Lead Sponsor:
Università Politecnica delle Marche
Collaborating Sponsors:
Noos S.r.l.
Conditions:
Celiac Disease
Eligibility:
All Genders
2-16 years
Phase:
NA
Brief Summary
Celiac disease (CD) is an inflammatory condition of the small intestine. Environmental and genetic factors are involved in the development of CD. Apart from environmental and genetic factors other fac...
Detailed Description
Celiac disease (CD) is an intestinal inflammatory condition characterized by permanent intolerance to gluten, a protein complex present in wheat, barley, and rye, in genetically predisposed subjects. ...
Eligibility Criteria
Inclusion
- Children / adolescents aged between 2 and 16 recruited at the time of diagnosis of celiac disease.
- The diagnosis of celiac disease will be performed according to the ESPGHAN 2012 Guidelines.
Exclusion
- Patients with autoimmune comorbidity (eg type 1 diabetes) or other associated chronic diseases
- Associated serum IgA selective deficiency
- Poor adherence to gluten free diet at the 6-month control, measured by a score\> 10 at the Wessels questionnaire.
- Adherence to the intervention protocol \<85%.
- Antibiotic therapy performed during the 7 days preceding T0 and / or T6.
- Antibiotic therapy during the 3 months of probiotic / placebo treatment.
Key Trial Info
Start Date :
March 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2021
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT03857360
Start Date
March 15 2019
End Date
August 15 2021
Last Update
October 4 2021
Active Locations (1)
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1
Department of Pediatrics, via Corridoni 11
Ancona, Italy, 60123