Gastrointestinal Diseases
Conditions
Keywords
GI, gastrointestinal, permeability, indometacin, indomethacin, coeliac
Brief summary
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.
Interventions
DRUGindometacin
* capsule for oral consumption * at 22h00 evening before test day: 75 mg * at 7h30 on the test day: 50 mg This intervention will be applied 4 times (4 arms).
Sponsors
Top Institute Food and Nutrition
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy controls, female/male, 18-75 years of age, OR: * coeliac disease without taking medicine, female/male, 18-75 years of age
Exclusion criteria
* 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 * Cancer * Smoking * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of permeability tests (new versus golden standard dual sugar test) | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| GI permeability | 24 hours |
Countries
Netherlands
Outcome results
None listed