Parabiotics Use with Nutritional Management in Pediatric Celiac Patients

NCT06870643 | Completed

• 1 other identifier: FMASU M S 697/2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease in Children

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 weeks

Study Arms (1)

Pediatric celiac patients

EXPERIMENTAL

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

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

Interventions

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.

Pediatric celiac patients

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Immunocompromised patients
• Patients taking immunosuppressant drugs or antibiotics within the last 4 weeks or during the study

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 1181, Egypt

Location

MeSH Terms

Interventions

Diet, Gluten-Free

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of pediatrics

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 11, 2025
• Study Start: July 12, 2023
• Primary Completion: December 26, 2024
• Study Completion: February 20, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

EG (1)