Parabiotics Use with Nutritional Management in Pediatric Celiac Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-12

Study Completion Date

2025-02-20

Brief Summary

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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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Detailed Description

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Conditions

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Celiac Disease in Children

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pediatric celiac patients

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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Gluten 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.

Intervention Type OTHER

Eligibility Criteria

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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