Parabiotics Use with Nutritional Management in Pediatric Celiac Patients

Ain Shams University

Status: Completed

Conditions: Celiac Disease in Children

Treatments: Other: Gluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT06870643

FMASU M S 697/2022

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Pediatric celiac patients

Experimental group

Description:

Strict gluten free food regimen for 3 weeks then parabiotics (Lacteolfort ®) added for another 3 weeks.

Treatment:

Other: Gluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeks