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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2015-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-17', 'studyFirstSubmitDate': '2017-06-01', 'studyFirstSubmitQcDate': '2017-06-01', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tissue transglutaminase autoantibodies (tTGA)', 'timeFrame': '6 months', 'description': 'To study levels of tTGA in children with ongoing celiac disease autoimmunity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Celiac Disease in Children']}, 'referencesModule': {'references': [{'pmid': '34054850', 'type': 'BACKGROUND', 'citation': 'Auricchio R, Troncone R. Can Celiac Disease Be Prevented? Front Immunol. 2021 May 14;12:672148. doi: 10.3389/fimmu.2021.672148. eCollection 2021.'}, {'pmid': '34495279', 'type': 'BACKGROUND', 'citation': 'Jedwab CF, Roston BCMB, Toge ABFS, Echeverria IF, Tavares GOG, Alvares MA, Rullo VEV, Oliveira MRM. The role of probiotics in the immune response and intestinal microbiota of children with celiac disease: a systematic review. Rev Paul Pediatr. 2021 Sep 1;40:e2020447. doi: 10.1590/1984-0462/2022/40/2020447. eCollection 2021.'}, {'pmid': '31426299', 'type': 'RESULT', 'citation': 'Hakansson A, Andren Aronsson C, Brundin C, Oscarsson E, Molin G, Agardh D. Effects of Lactobacillus plantarum and Lactobacillus paracasei on the Peripheral Immune Response in Children with Celiac Disease Autoimmunity: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients. 2019 Aug 16;11(8):1925. doi: 10.3390/nu11081925.'}, {'pmid': '34249990', 'type': 'RESULT', 'citation': 'Oscarsson E, Hakansson A, Andren Aronsson C, Molin G, Agardh D. Effects of Probiotic Bacteria Lactobacillaceae on the Gut Microbiota in Children With Celiac Disease Autoimmunity: A Placebo-Controlled and Randomized Clinical Trial. Front Nutr. 2021 Jun 25;8:680771. doi: 10.3389/fnut.2021.680771. eCollection 2021.'}, {'pmid': '37485388', 'type': 'DERIVED', 'citation': 'Jenickova E, Andren Aronsson C, Mascellani Bergo A, Cinek O, Havlik J, Agardh D. Effects of Lactiplantibacillus plantarum and Lacticaseibacillus paracasei supplementation on the faecal metabolome in children with coeliac disease autoimmunity: a randomised, double-blinded placebo-controlled clinical trial. Front Nutr. 2023 Jul 6;10:1183963. doi: 10.3389/fnut.2023.1183963. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nMethods: 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.\n\nBlood samples were drawn at 0, 3 and 6 months and analyzed for both IgA-tTGA and IgG-tTGA using radioligand binding assays.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Carrier of any of the HLA-types DQ2 and/or DQ8 associated with celiac disease.\n* Screened positive for tissue transglutaminase autoantibodies (tTGA) in at least 2 consecutive blood draws (\\<30U/ml).\n* No celiac disease diagnose\n* Currently on a normal gluten-containing diet\n\nExclusion Criteria:\n\n* Screened positive for Type 1 diabetes associated autoantibodies (GADA, IAA, IA-2A, ZnT8A).'}, 'identificationModule': {'nctId': 'NCT03176095', 'acronym': 'CiPP', 'briefTitle': 'Celiac Disease Prevention With Probiotics', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Celiac Disease Prevention With Probiotics', 'orgStudyIdInfo': {'id': '2011/335'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic Group', 'description': '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.\n\nThe probiotic product consisted of two different bacterial strains.', 'interventionNames': ['Dietary Supplement: Probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'The participants in the Placebo group were provided with dietary supplements in the form as sachets with maltodextrin for daily intake (1 per day).', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Probiotic Group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Daniel Agardh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}