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Celiac Disease Prevention With Probiotics (CiPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03176095
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : November 22, 2021
Information provided by (Responsible Party):
Lund University

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
Celiac Disease in Children Dietary Supplement: Probiotic Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : March 1, 2012
Actual Primary Completion Date : August 30, 2015
Actual Study Completion Date : August 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

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

Primary Outcome Measures :
  1. Tissue transglutaminase autoantibodies (tTGA) [ Time Frame: 6 months ]
    To study levels of tTGA in children with ongoing celiac disease autoimmunity

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03176095

Sponsors and Collaborators
Lund University
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Principal Investigator: Daniel Agardh, MD, PhD Lund University
Publications of Results:
Other Publications:
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Responsible Party: Lund University Identifier: NCT03176095    
Other Study ID Numbers: 2011/335
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases