Celiac Disease Prevention With Probiotics

Background/Aim: Celiac disease is a common immune-mediated disorder, and the only currently available treatment is a gluten-free diet. Recent studies have shown several probiotics to carry properties that might positively influence the immunological activity in celiac patients.

The aim of the present study is to investigate how daily consumption of probiotics would affect levels of tissue transglutaminase autoantibodies (tTGA), markers of celiac disease autoimmunity in the periphery, as compared to placebo in children at genetic risk for celiac disease.

Methods: Between 2012 and 2015, 90 children were recruited from two ongoing prospective celiac disease screening studies at the Skåne University Hospital, Sweden. Participants were randomized to either daily consumption of 2 lactobacilli strains or placebo for the duration of 6 months.

Blood samples were drawn at 0, 3 and 6 months and analyzed for both IgA-tTGA and IgG-tTGA using radioligand binding assays.

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Key information

Conditions

Celiac Disease in Children

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Carrier of any of the HLA-types DQ2 and/or DQ8 associated with celiac disease.
Screened positive for tissue transglutaminase autoantibodies (tTGA) in at least 2 consecutive blood draws (<30U/ml).
No celiac disease diagnose
Currently on a normal gluten-containing diet

Exclusion criteria

Screened positive for Type 1 diabetes associated autoantibodies (GADA, IAA, IA-2A, ZnT8A).

Treatment and study plan

Probiotic

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

Tissue transglutaminase autoantibodies (tTGA)

Time frame: 6 months

To study levels of tTGA in children with ongoing celiac disease autoimmunity

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Acronym: CiPP

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Jun 5, 2017
Registry last updated: Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed