Validation of New Tests for Gastrointestinal (GI) Permeability (Permeability)

November 7, 2011 updated by: Kim van Wijck, Maastricht University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Indometacin [Actavis]
Other: 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 Names:
  • Indometacin [Actavis]
Other: 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 Names:
  • Indometacin [Actavis]
Other: 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 Names:
  • Indometacin [Actavis]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of permeability tests (new versus golden standard dual sugar test)
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
GI permeability
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Top Institute Food and Nutrition

Investigators

  • Principal Investigator: WA Buurman, Prof.dr., Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

February 1, 2012

Study Completion (Anticipated)

February 1, 2012

Study Registration Dates

First Submitted

July 21, 2009

First Submitted That Met QC Criteria

July 21, 2009

First Posted (Estimate)

July 22, 2009

Study Record Updates

Last Update Posted (Estimate)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 09-3-034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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