Validation of New Tests for Gastrointestinal (GI) Permeability

Gastrointestinal Diseases Clinical Trial

— Permeability  

Official title:

Dubbelblind Crossover Study for Validation of New Tests for Gastrointestinal (GI) Permeability

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00943345
• Other study ID #: MEC 09-3-034
• Status: Enrolling by invitation
• Phase: Phase 0
• First received: July 21, 2009
• Last updated: November 7, 2011
• Start date: September 2009
• Est. completion date: February 2012

Study information

• Verified date: November 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 34
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Drug:
• indometacin
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).

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Zuid-Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of permeability tests (new versus golden standard dual sugar test)		24 hours	No
Secondary	GI permeability		24 hours	No