Cytokine Profile in Children With Celiac Disease

NCT02244047 | Completed Phase 1

• 1 other identifier: CEL-BIF
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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

1. 1.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.
2. 2.3 months after daily probiotic consumption TNF-alpha level decrease and IL-10 level increase.
3. 3.Group: 25 children with celiac disease on GFD for at least 3 months and will receive probiotic for 3 months.
4. 4.Group: 25 children with celiac disease on GFD for at least 3 months and will receive placebo for 3 months.
5. 5.Group: 20 healthy children

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (1)

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

  3 months

Study Arms (2)

Bifidobacterium breve

ACTIVE COMPARATOR

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

Drug: Bifidobacterium breve

Placebo

ACTIVE COMPARATOR

Placebo in the same powder packages as Bifidobacterium breve

Drug: Placebo (for Bifidobacterium breve)

Interventions

Bifidobacterium breve DRUG

Bifidobacterium breve

Placebo (for Bifidobacterium breve) DRUG

Placebo

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• celiac disease on gluten free diet

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Centre Maribor: lead
• Slovenian Research Agency: collaborator

Related Publications (1)

• 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.

  PMID: 26134988 DERIVED

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Martina Klemenak, md

  University Medical Centre Maribor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor, resident at Pediatric department

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 18, 2014
• Study Start: October 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 18, 2014

Record last verified: 2014-09