Validation of New Tests for Gastrointestinal (GI) Permeability - Full Text View

Sponsor:	Maastricht University Medical Center
Collaborator:	Top Institute Food and Nutrition
Information provided by (Responsible Party):	Kim van Wijck, Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00943345

Purpose

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.

Condition	Intervention	Phase
Gastrointestinal Diseases	Drug: indometacin	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	Dubbelblind Crossover Study for Validation of New Tests for Gastrointestinal (GI) Permeability

Resource links provided by NLM:

MedlinePlus related topics: Celiac Disease

Drug Information available for: Indomethacin

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

Comparison of permeability tests (new versus golden standard dual sugar test) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

GI permeability [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	34
Study Start Date:	September 2009
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	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). Other Name: Indometacin [Actavis]
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.	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). Other Name: Indometacin [Actavis]
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.	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). Other Name: Indometacin [Actavis]
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.	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). Other Name: Indometacin [Actavis]

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943345

Locations

Netherlands
Maastricht University Medical Center
Maastricht, Zuid-Limburg, Netherlands

Sponsors and Collaborators

Maastricht University Medical Center

Top Institute Food and Nutrition

Investigators

Principal Investigator:

WA Buurman, Prof.dr.

Maastricht University Medical Center

More Information

No publications provided

Responsible Party:	Kim van Wijck, MD, PhD student, Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00943345 History of Changes
Other Study ID Numbers:	MEC 09-3-034
Study First Received:	July 21, 2009
Last Updated:	November 7, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:

GI
gastrointestinal
permeability

indometacin
indomethacin
coeliac

Additional relevant MeSH terms:

Gastrointestinal Diseases
Digestive System Diseases
Indomethacin
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012