Celiac Disease Prevention With Probiotics (CiPP)
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| ClinicalTrials.gov Identifier: NCT03176095 |
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Recruitment Status :
Completed
First Posted : June 5, 2017
Last Update Posted : November 22, 2021
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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 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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 |
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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).
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Dietary Supplement: Placebo |
- Tissue transglutaminase autoantibodies (tTGA) [ Time Frame: 6 months ]To study levels of tTGA in children with ongoing celiac disease autoimmunity
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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).
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 ClinicalTrials.gov identifier (NCT number): NCT03176095
| Principal Investigator: | Daniel Agardh, MD, PhD | Lund University |
Other Publications:
| Responsible Party: | Lund University |
| ClinicalTrials.gov 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Celiac Disease Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |