Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Metabolic status
研究概览
简要总结
The research aims to investigate the effects of gluten-free oats to the gastrointestinal health in celiac disease patients and healthy subjects. The effects of gluten-free oats on the several intestinal parameters, on the composition of the gut microbiota as well as on the metabolic profile of celiac patients and healthy controls will be studied. The study is divided into two parts.
Part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over study. Healthy subjects will be recruited to the study. The aim is to recruit 15 participants for the part 1. The study will be conducted with a cross-over setting, where the subjects will go through exposure meals and SmartPill ingestion three times (two different oat products and placebo) in a randomized order. The study meals are identical in appearance and fiber content. After consuming the meal subjects will ingest the SmartPill capsule, which will send data on intestinal pH, pressure and temperature to the external portable device. Before and during the passage of capsule the subjects will fill a symptom and food diary. The capsule will exit the body in 1 to 3 days and the data collected by the external device will be collected and analyzed. Before the oat/placebo exposure the subjects will give a fecal and a blood sample. In addition, 36 hours urine samples will be collected.
In part 2 celiac disease patients, non-celiac gluten sensitive subjects and healthy controls will be recruited and they will be divided into four groups: oat-avoiding celiacs (1), oat-consuming celiacs (2), non-celiac gluten sensitive subjects (3) and healthy controls (4). Recruiting aim for each group is 15 subjects. In addition to dietary data, a blood, and a fecal sample will be collected from the subjects. The gut microbiota will be analyzed from the fecal samples. The metabolic products will be analyzed from the fecal, urine and blood samples. The gut microbiota composition will be analyzed with next-generation DNA sequencing techniques.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Celiac disease diagnosed with duodenal biopsy (only celiac groups)
- •In remission and maintained gluten-free diet >1 year (only celiac groups)
- •Usage of oats in their diet (only oat-using celiacs and healthy controls)
- •BMI 18,5 - 30
- •Normal liver, thyroid and kidney functions
排除标准
- •Medication that majorly affects GI tract (e.g. laxatives, antacids)
- •Antibiotic treatment within the last 6 months
- •Blood donation or participating in another clinical trial within the last month
结局指标
主要结局
Metabolic status
时间窗: Measured from single time point sampling
Metabolic status analyzed by the amount of metabolic products found in fecal, urine and serum samples
Fecal microbiota composition
时间窗: Measured from single time point sampling
Fecal microbiota diversity and composition analyzed from fecal sample
次要结局
未报告次要终点
研究者
Kaisa Linderborg
Professor of Molecular Food Sciences (acting)
University of Turku