Gastrointestinal DiseasesEarly Phase 1PermeabilityNCT00943345
Validation of New Tests for Gastrointestinal (GI) Permeability
A Early Phase 1 study testing indometacin in people with Gastrointestinal Diseases, run by Maastricht University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- indometacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2009to Feb 2012
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy controls, female/male, 18-75 years of age, OR:
- coeliac disease without taking medicine, female/male, 18-75 years of age
Who cannot join
- 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
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Zuid-Limburg
About this study
Official title: 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.
- Conditions
- Gastrointestinal Diseases
- Being tested
- indometacin
- Keywords
- GI, gastrointestinal, permeability, indometacin, indomethacin, coeliac
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indometacinDrug
Also called Indometacin [Actavis]
- 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).
| Study group | Role | What they receive |
|---|---|---|
| GS dual sugar permeability test | Active comparator | 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. Receives: Drug: indometacin |
| Multi sugar test | Other | 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. Receives: Drug: indometacin |
| Protein test | Other | 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. Receives: Drug: indometacin |
| PEG test | Other | 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. Receives: Drug: indometacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of permeability tests (new versus golden standard dual sugar test)
Measured: 24 hours
Secondary outcomes (1)
GI permeability
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Responsible party
- Principal investigator, Kim van Wijck, Maastricht University Medical Center
- Investigators
- WA Buurman, Prof.dr., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943345
- Sponsor's protocol ID
- MEC 09-3-034
- Acronym
- Permeability
- Status last verified
- Nov 2011
- First submitted
- 21 Jul 2009
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van Wijck K, Verlinden TJ, van Eijk HM, Dekker J, Buurman WA, Dejong CH, Lenaerts K. Novel multi-sugar assay for site-specific gastrointestinal permeability analysis: a randomized controlled crossover trial. Clin Nutr. 2013 Apr;32(2):245-51. doi: 10.1016/j.clnu.2012.06.014. Epub 2012 Aug 11.
PubMed 22892368
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dubbelblind Crossover Study for Validation of New Tests for Gastrointestinal (GI) Permeability
- ClinicalTrials.gov ID
- NCT00943345
- Acronym / sponsor ID
- Permeability / MEC 09-3-034
- Conditions
- Gastrointestinal Diseases
- Keywords
- GI, gastrointestinal, permeability, indometacin, indomethacin, coeliac
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Sep 2009
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GS dual sugar permeability test | Active comparator | Drug: indometacinGolden 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. |
| Multi sugar test | Other | Drug: indometacinNew 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. |
| Protein test | Other | Drug: indometacinNew 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. |
| PEG test | Other | Drug: indometacinNew 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy controls, female/male, 18-75 years of age, OR:
- coeliac disease without taking medicine, female/male, 18-75 years of age
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indometacinAlso: Indometacin [Actavis]* 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). | Drug | GS dual sugar permeability test, Multi sugar test, PEG test, Protein test |
Primary outcome
Comparison of permeability tests (new versus golden standard dual sugar test)
Time frame: 24 hours
1 secondary outcome
GI permeability
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
- Derived from this study: PubMed 22892368van Wijck K, Verlinden TJ, van Eijk HM, Dekker J, Buurman WA, Dejong CH, Lenaerts K. Novel multi-sugar assay for site-specific gastrointestinal permeability analysis: a randomized controlled crossover trial. Clin Nutr. 2013 Apr;32(2):245-51. doi: 10.1016/j.clnu.2012.06.014. Epub 2012 Aug 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WA Buurman, Prof.dr. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing indometacin in people with Gastrointestinal Diseases, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of permeability tests (new versus golden standard dual sugar test) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00943345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.