Dubbelblind Crossover Study for Validation of New Tests for Gastrointestinal (GI) Permeability
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Comparison of permeability tests (new versus golden standard dual sugar test)
研究概览
简要总结
Introduction: The primary function of the gastrointestinal (GI) wall is digestion and absorption of nutrients that are important for growth and development. The second important function of the GI wall is forming an effective barrier to prevent penetration of potentially harmful components from the inside of the gut (lumen), via the GI wall, into the body.
A compromised barrier function may play an important role in the development of a range of inflammatory GI diseases such as coeliac disease, Inflammatory Bowel Disease (IBD), food allergy, but also in the pathophysiology of postoperative complications. It is important and clinically relevant to have reliable GI permeability tests, however the existing test leave room for improvement.
Rationale/aim: Three new tests are developed to assess gastrointestinal permeability in both normal controls with and without raised permeability, and in patients with coeliac disease. In the current study these new permeability tests will be evaluated and compared with the golden standard permeability test, the dual sugar test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •healthy controls, female/male, 18-75 years of age, OR:
- •coeliac disease without taking medicine, female/male, 18-75 years of age
排除标准
- •cardiac and/or vascular disease
- •chronic obstructive pulmonary disease (COPD)
- •rheumatic arthritis (RA)
- •Inflammatory bowel disease(IBD); Crohn's colitis or colitis ulcerosa
- •Irritable bowel syndrome (IBS)
- •Inflammatory systemic disease
- •Obesity (Body Mass Index ≥ 30 kg/m²)
- •Diabetes Mellitus
- •Thyroid disease
- •Kidney disease
- •Substance abuse (alcohol, drug, cocain, opioids, and others)
- •Use of drugs
- •Operations to the GI system, apart from appendectomy
- •Allergy to eggs or milk
- •Hypersensitivity to any of the following: lactulose, l-rhamnose, sucrose, sucralose of erythritol
- •Acute porphyria or phenylketonuria (PKU)
- •Pregnancy
研究组 & 干预措施
GS dual sugar permeability test
Golden standard GI permeability test - testing occurs for basal permeability (with placebo) and after ingestion of indometacin (for normal controls).
Coeliac patients will only have 1 test to assess basal GI permeability.
干预措施: indometacin (Drug)
Multi sugar test
New GI permeability test - testing occurs for basal permeability (with placebo) and after ingestion of indometacin (for normal controls).
Coeliac patients will only have 1 test to assess basal GI permeability.
干预措施: indometacin (Drug)
Protein test
New GI permeability test - testing occurs for basal permeability (with placebo) and after ingestion of indometacin (for normal controls).
Coeliac patients will only have 1 test to assess basal GI permeability.
干预措施: indometacin (Drug)
PEG test
New GI permeability test - testing occurs for basal permeability (with placebo) and after ingestion of indometacin (for normal controls).
Coeliac patients will only have 1 test to assess basal GI permeability.
干预措施: indometacin (Drug)
结局指标
主要结局
Comparison of permeability tests (new versus golden standard dual sugar test)
时间窗: 24 hours
次要结局
- GI permeability(24 hours)
研究者
Kim van Wijck
MD, PhD student
Maastricht University Medical Center