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CiPP: Celiac Disease Prevention With Probiotics

Sponsor
Lund University (Other)
Overall Status
Completed
CT.gov ID
NCT03176095
Collaborator
(none)
90
Enrollment
2
Arms
42
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotic
  • Dietary Supplement: Placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-blind
Primary Purpose:
Prevention
Official Title:
Celiac Disease Prevention With Probiotics
Actual Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Aug 30, 2015
Actual Study Completion Date :
Aug 30, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Probiotic Group

The participants in the Probiotic group were provided with dietary supplements in the form as sachets with freeze dried bacteria (active lactobacilli culture) mixed with maltodextrin for daily intake (1 per day). The powder was dissolved in water or other non-alcoholic cold drink mixed with fruit before ingestion. The probiotic product consisted of two different bacterial strains.

Dietary Supplement: Probiotic
Placebo Comparator: Placebo Group

The participants in the Placebo group were provided with dietary supplements in the form as sachets with maltodextrin for daily intake (1 per day).

Dietary Supplement: Placebo

Outcome Measures

Primary Outcome Measures

  1. Tissue transglutaminase autoantibodies (tTGA) [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Lund University

Investigators

  • Principal Investigator: Daniel Agardh, MD, PhD, Lund University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Lund University
ClinicalTrials.gov Identifier:
NCT03176095
Other Study ID Numbers:
  • 2011/335
First Posted:
Jun 5, 2017
Last Update Posted:
Nov 22, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Celiac Disease

Study Results

No Results Posted as of Nov 22, 2021