DRKS00033108已完成Unknown
Release of X-Pro dipeptides and amino acids from stable isotope-labelled gluten-related immunogenic peptided by AMY01 - AMY01-POC
niversitätsmedizin Greifswald0 个研究点目标入组 16 人开始时间: 2023年11月28日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •understands the study purpose and design
- •- contractually capable and provides signed informed consent form
- •- healthy condition or mild and/or well treated forms of allergies, asthma,
- •hypertension, and orthopedic diseases
排除标准
- •a.BMI > 35 kg/m2 and <18 kg/m2
- •b.known pregnancy or lactation period
- •c.women: positive urine pregnancy test at screening or visit
- •d.anemia (Hb < 13 g/dl (8,07 mmol/l) in men or < 12 g/dl (7,45 mmol/l)
- •e.blood donation within the last 4 weeks
- •f.elevated liver function tests (ALAT, ASAT, yGT, Bilirubin > 2x ULN)
- •g.reduced renal function (eGFR MDRD < 60 ml/min/1,7m2)
- •h.known history of celiac disease or gluten intolerance
- •i.known gastrointestinal disease
- •j.intake of proton pump inhibitors
- •k.prescription of > 2 drugs taken during the screening and study visits
- •l.psychiatric disease or drug dependency
- •m.use of recreational drugs more than twice a week
- •n.poor venous conditions that make it impossible to place a peripheral
- •venous catheter and regularly draw blood through it
研究者
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