Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2012-03-01
2015-08-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
Probiotic
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).
Placebo
Interventions
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Probiotic
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
2 Years
12 Years
ALL
Yes
Sponsors
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Lund University
OTHER
Responsible Party
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Principal Investigators
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Daniel Agardh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Lund University
References
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Auricchio R, Troncone R. Can Celiac Disease Be Prevented? Front Immunol. 2021 May 14;12:672148. doi: 10.3389/fimmu.2021.672148. eCollection 2021.
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.
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.
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.
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.
Other Identifiers
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2011/335
Identifier Type: -
Identifier Source: org_study_id