Trials / Completed
CompletedNCT03176095
Celiac Disease Prevention With Probiotics
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Lund University · Academic / Other
- Sex
- All
- Age
- 2 Years – 12 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Probiotic | |
| DIETARY_SUPPLEMENT | Placebo |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2015-08-30
- Completion
- 2015-08-30
- First posted
- 2017-06-05
- Last updated
- 2021-11-22
Source: ClinicalTrials.gov record NCT03176095. Inclusion in this directory is not an endorsement.