Validation of New Tests for Gastrointestinal (GI) Permeability

Maastricht University Medical Centre (MUMC)

Status and phase: Unknown; Early Phase 1

Conditions: Gastrointestinal Diseases

Treatments: Drug: indometacin

Study type: Interventional

Funder types: Other

Identifiers

NCT00943345

MEC 09-3-034

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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34 participants in 4 patient groups

GS dual sugar permeability test

Active Comparator group

Description:

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.

Treatment:

Drug: indometacin

Multi sugar test

Other group

Description:

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.

Treatment:

Drug: indometacin

Protein test

Other group

Description:

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.

Treatment:

Drug: indometacin

PEG test

Other group

Description:

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.

Treatment:

Drug: indometacin