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Cytokine Profile in Children With Celiac Disease

Primary Purpose

Celiac Disease

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Bifidobacterium breve

Placebo (for Bifidobacterium breve)

About this trial

This is an interventional prevention trial for Celiac Disease

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

celiac disease on gluten free diet

Exclusion Criteria:

acute or chronic diseases,
permanent use of medication and
ingestion of antibiotics at least one month prior to study

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Bifidobacterium breve

Placebo

Arm Description

Bifidobacterium breve BR03 and B632 powder containing 10/9 CFU daily dosage in a period of 3 months

Placebo in the same powder packages as Bifidobacterium breve

Outcomes

Primary Outcome Measures

Serum TNF-alpha decrease after Bifidobacterium breve daily consumption in children with celiac disease

Secondary Outcome Measures

Full Information

NCT ID

NCT02244047

First Posted

September 16, 2014

Last Updated

September 17, 2014

Sponsor

University Medical Centre Maribor

Collaborators

Slovenian Research Agency

1. Study Identification

Unique Protocol Identification Number

NCT02244047

Brief Title

Cytokine Profile in Children With Celiac Disease

Official Title

Exploratory, Placebo-controlled Study on the Effects of Bifidobacterium Breve in Children With Celiac Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Medical Centre Maribor

Collaborators

Slovenian Research Agency

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Celiac disease (CD) is an immune-mediated systemic disease that is elicited by consumption of gluten and related prolamines in genetically susceptible individuals. Not only genetic but also environmental factors play an important role in CD pathogenesis. CD patients have imbalance in the gut microbiota, they have reduced number of Bididobacterium species in feces and biopsies. Up till now, only effective treatment for CD is life long adherence to gluten free diet. If gluten free diet is not strict that leads over the years to complications of disease, such as autoimmune diseases, psychiatric diseases, osteoporosis etc. That may be caused by continuous recirculation of activated immune cells between the inflamed organ and the periphery. To avoid complications of disease in long term the investigators want to test specific probiotic bacteria from Bifidobacteria genus, that has has been in vitro studies recognized as anti-inflammatory. Hypothesis Children with celiac disease on gluten free diet have a higher level of pro-inflammatory cytokine (TNF-alpha) and anti-inflammatory cytokine (IL-10) in comparison with healthy controls. 3 months after daily probiotic consumption TNF-alpha level decrease and IL-10 level increase. In the investigators research will be selected 70 children, age from 2 to 18 years, divided in different groups: Group: 25 children with celiac disease on GFD for at least 3 months and will receive probiotic for 3 months. Group: 25 children with celiac disease on GFD for at least 3 months and will receive placebo for 3 months. Group: 20 healthy children

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Celiac Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bifidobacterium breve

Arm Type

Active Comparator

Arm Description

Bifidobacterium breve BR03 and B632 powder containing 10/9 CFU daily dosage in a period of 3 months

Arm Title

Placebo

Arm Type

Active Comparator

Arm Description

Placebo in the same powder packages as Bifidobacterium breve

Intervention Type

Drug

Intervention Name(s)

Bifidobacterium breve

Intervention Type

Drug

Intervention Name(s)

Placebo (for Bifidobacterium breve)

Primary Outcome Measure Information:

Title

Serum TNF-alpha decrease after Bifidobacterium breve daily consumption in children with celiac disease

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: celiac disease on gluten free diet Exclusion Criteria: acute or chronic diseases, permanent use of medication and ingestion of antibiotics at least one month prior to study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martina Klemenak, md

Organizational Affiliation

University Medical Centre Maribor

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

26134988

Citation

Klemenak M, Dolinsek J, Langerholc T, Di Gioia D, Micetic-Turk D. Administration of Bifidobacterium breve Decreases the Production of TNF-alpha in Children with Celiac Disease. Dig Dis Sci. 2015 Nov;60(11):3386-92. doi: 10.1007/s10620-015-3769-7. Epub 2015 Jul 2.

Results Reference

derived

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Cytokine Profile in Children With Celiac Disease

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