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Prebiotic as a Supplement of Gluten-free Diet in the Management of Celiac Disease in Children

NCT03064997 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-10-29

No results posted yet for this study

Summary

Prebiotics are known as substances affecting beneficially the organism by restoring the intestinal microbiota balance, stabilizing the intestinal barrier and modulating the endocrine and immune functions. In many persons suffering from celiac disease (CD), despite a gluten-free diet (GFD), an impaired intestinal barrier functionality, accompanied by altered intestinal microbiota and ongoing intestinal inflammation is observed. For these reasons, prebiotic could be a promising and low-risk adjuvant in the dietetic management of CD. It was hypothesize that prebiotic preparation Synergy 1 consumed by CD children as a supplement of a GFD will affect beneficial the intestinal permeability and intestinal microbiota without side effects.

Conditions

Interventions

DIETARY_SUPPLEMENT

Synergy 1

a daily dose: 7 g/day of Synergy1 (oligofructose enriched inulin) consumed for 12 weeks together with a strict gluten-free diet

DIETARY_SUPPLEMENT

Placebo

a daily dose: 7 g/day of placebo (maltodextrin) consumed for 12 weeks together with a strict gluten-free diet

Sponsors & Collaborators

  • University of Warmia and Mazury

    collaborator OTHER

  • Polish Academy of Sciences

    lead OTHER

Principal Investigators

  • Urszula Krupa-Kozak, Ph.D · Institute of Animal Reproduction and Food Reseach, Polish Academy of Sciences in Olsztyn

  • Elżbieta Jarocka-Cyrta, MD, Ph.D · Department of Clinical Pediatrics, Faculty of Medical Sciences, University of Warmia and Mazury

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-12
Primary Completion
2016-03-01
Completion
2016-06-01

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03064997 on ClinicalTrials.gov