In-vivo Study of the Efficacy of Hyperimmune Bovine Colostrum to Block Absorption of Gliadin Peptides in the Human Intestine: a Novel Potential Intervention for Celiac Disease and Non-celiac Gluten Sensitivity
试验速览
- 阶段
- 早期 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Gluten immunogenic peptides in urine
研究概览
简要总结
To investigate the use of hyperimmune bovine colostrum to reduce gluten absorption.
A double-blind, cross-over study will be performed in which persons who are following a strict gluten-free diet will be challenged with oral gluten with or without the bovine colostrum.
详细描述
Physiologic double-blind, cross-over, study in which volunteers on a gluten-free diet will ingest gluten with or without colostrum.
Subject Participation and Study Duration
The study will imply 5 visits for each participant. At the second and fourth visit, they will either take gluten with colostrum powder or with a placebo. Follow-up duration will be until three days after the last study visit.
Each participant will be given daily proton pump inhibitor (PPI) therapy (omeprazole 20 mg) at least one week before the first intervention, and for the entire duration of the study.
Each participant will be invited to fill a celiac disease patient reported outcomes questionnaire (Celiac Disease Symptoms Diary) for the 24 hours prior the study intervention and three days after. Blood and urine samples will be collected during the 24 hours following each study intervention (gluten + colostrum or gluten + placebo)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Both participant and investigator will not be aware whether subject is having the colostrum or the placebo
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-reported strict adherence to a gluten-free diet for at least 3 months. This may be a lifestyle choice, in solidarity with a child or other family/household member with celiac disease, because of non-celiac gluten sensitivity or because of celiac disease.
- •Willing to provide informed consent for all study procedures
- •Healthy volunteer according to the investigator assessment (history and physical exam)
排除标准
- •Definite or probable gluten exposure during the 72 hours preceding each study intervention visit
- •Known active gastrointestinal disease.
- •Use of an oral digestive enzyme supplement during the 72 hours preceding each study intervention (challenge) visit.
- •History of severe symptomatic reactions to gluten or milk proteins
- •History of allergy to beef or meat
- •History of allergy to apple
- •Severe lactose intolerance
- •Any medication or medical condition which, in the opinion of the investigators, could adversely affect the patient's participation in the trial.
- •Allergy to PPI or other contraindication for PPI use (i.e history of interstitial nephritis attributed to PPI, history of PPI-induced diarrhea)
- •Pregnant women (according to pregnancy test)
结局指标
主要结局
Gluten immunogenic peptides in urine
时间窗: 24 hours
The main outcome measure will be the intra-subject area under the curve (AUC) for gluten immunogenic peptides measured in urine following gluten challenge with placebo compared to the AUC for gluten immunogenic peptides following gluten challenge combined with colostrum
次要结局
- Symptom score(24 hours)