Cytokine Profile in Children With Celiac Disease

Sponsor

University Medical Centre Maribor (Other)

Overall Status

Completed

CT.gov ID

NCT02244047

Collaborator

Slovenian Research Agency (Other)

Enrollment

Arms

Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Celiac Disease	Drug: Bifidobacterium breve Drug: Placebo (for Bifidobacterium breve)	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bifidobacterium breve Bifidobacterium breve BR03 and B632 powder containing 10/9 CFU daily dosage in a period of 3 months	Drug: Bifidobacterium breve
Active Comparator: Placebo Placebo in the same powder packages as Bifidobacterium breve	Drug: Placebo (for Bifidobacterium breve)

Arm

Intervention/Treatment

Active Comparator: Bifidobacterium breve

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

Drug: Bifidobacterium breve

Active Comparator: Placebo

Placebo in the same powder packages as Bifidobacterium breve

Drug: Placebo (for Bifidobacterium breve)

Outcome Measures

Primary Outcome Measures

Serum TNF-alpha decrease after Bifidobacterium breve daily consumption in children with celiac disease [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Medical Centre Maribor
Slovenian Research Agency

Investigators

Principal Investigator: Martina Klemenak, md, University Medical Centre Maribor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Martina Klemenak, medical doctor, resident at Pediatric department, University Medical Centre Maribor

ClinicalTrials.gov Identifier:

NCT02244047

Other Study ID Numbers:

CEL-BIF

First Posted:

Sep 18, 2014

Last Update Posted:

Sep 18, 2014

Last Verified:

Sep 1, 2014

Additional relevant MeSH terms:

Celiac Disease

Study Results

No Results Posted as of Sep 18, 2014