Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2026-01-03 @ 5:10 PM
Study NCT ID:
NCT03176095
Status:
COMPLETED
Last Update Posted:
2021-11-22
First Post:
2017-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celiac Disease Prevention With Probiotics
Sponsor:
Lund University
Organization:
Study Overview
Official Title:
Celiac Disease Prevention With Probiotics
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CiPP
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: