Celiac Disease Prevention With Probiotics (CiPP)
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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).
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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. |
|
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安慰剂比较：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).
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Tissue transglutaminase autoantibodies (tTGA)
大体时间：6 months
|
To study levels of tTGA in children with ongoing celiac disease autoimmunity
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6 months
|
合作者和调查者
调查人员
- 首席研究员：Daniel Agardh, MD, PhD、Lund University
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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