Parabiotics Use with Nutritional Management in Pediatric Celiac Patients

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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Key information

Conditions

Celiac Disease in Children

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Abbassia, 1181, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Evaluate the effect of parabiotics as an adjuvant on celiac patients' quality of life .

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effect of Parabiotics As an Adjuvant in Nutritional Management of Pediatric Celiac Patients

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2025
First posted: Mar 11, 2025
Registry last updated: Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed