Intestinal PermeabilityGut-PermNCT07066176
Establishing and Validating a Meal-provoked Intestinal Permeability Test for Nutritional and Metabolic Health Clinical Research.
A study testing Aspirin and Mixed meal beverage in people with Intestinal Permeability, run by Laval University at 1 site in Canada.
Trial summary
Development of Intestinal Permeability Tests for Clinical Nutrition and Metabolic Health Studies Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Permeability
- What is being tested?
- Aspirin and Mixed meal beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jul 2025to 15 Aug 2025
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women
- 18-65y
- BMI <40
Who cannot join
- Enteropathies
- Food intolerance or allergy related to the protocol
- Pregnancy or breastfeeding within the last 3 months
- Contraindications for aspirin - see Monograph
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Intestinal Permeability Tests for Clinical Nutrition and Metabolic Health Studies
Development of Intestinal Permeability Tests for Clinical Nutrition and Metabolic Health Studies
Read the detailed description
Crossover clinical trial on 10 subjects (5 women, 5 men) with 3 intestinal permeability tests (3-day washout) as follows: 1) fasting; 2) meal-provoked; and 3) meal-provoked with acute aspirin challenge to assess the test's feasibility and capacity to detect alterations in intestinal permeability after aspirin-induced intestinal barrier defects.
Each test will be performed after a 12h fast. Subjects will provide fasting blood and urine samples, fully empty their bladders and drink 50mL of water with/without soluble aspirin (650mg). After 30 min., subjects will drink 500mL of water or mixed meal beverage (22g protein, 26g fat, 52g carbs) with mannitol (2g) and lactulose (4g). A standardized snack and water (200mL) will be provided at 3h. Blood samples will be taken at 2h, 3h and 4h. All urine will be collected over 5 hours. Collection times were adapted to account for potential delays in gastric emptying (mixed meal vs. water). Lactulose-to-mannitol ratios, by HPAEC-PAD method, in urine and blood will be compared by phases using mixed linear models.
- Conditions
- Intestinal Permeability
- Being tested
- Aspirin, Mixed meal beverage
- Keywords
- intestinal permeability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Aspirin 650mg prior mixed meal beverage
Mixed meal beverageDietary supplement
Mixed meal beverage
| Study group | Role | What they receive |
|---|---|---|
| Water | No intervention | Mannitol and lactulose diluted in water (500mL) |
| Mixed meal beverage | Placebo comparator | Mannitol and lactulose diluted in mixed meal beverage (500mL) Receives: Dietary Supplement: Mixed meal beverage |
| Mixed meal beverage and aspirin | Experimental | Aspirin (650mg) prior to mannitol and lactulose diluted in mixed meal beverage (500mL) Receives: Drug: Aspirin; Dietary Supplement: Mixed meal beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal permeability
lactulose-to-mannitol ratio in urine
Measured: From baseline to hour 5
Secondary outcomes (1)
Intestinal permeability
lactulose-to-mannitol ratio in plasma
Measured: At baseline, hour 2, hour 3 and hour 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start7 Jul 2025
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal PermeabilityStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alain Veilleux, Laval University
- Investigators
- Alain Veilleux, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066176
- Sponsor's protocol ID
- 2025-178
- Acronym
- Gut-Perm
- Status last verified
- Sep 2025
- First submitted
- 30 Jun 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Intestinal Permeability Tests for Clinical Nutrition and Metabolic Health Studies
- ClinicalTrials.gov ID
- NCT07066176
- Acronym / sponsor ID
- Gut-Perm / 2025-178
- Conditions
- Intestinal Permeability
- Keywords
- intestinal permeability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 15 Jul 2025 (actual)
- 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.
Development of Intestinal Permeability Tests for Clinical Nutrition and Metabolic Health Studies
Detailed description
Crossover clinical trial on 10 subjects (5 women, 5 men) with 3 intestinal permeability tests (3-day washout) as follows: 1) fasting; 2) meal-provoked; and 3) meal-provoked with acute aspirin challenge to assess the test's feasibility and capacity to detect alterations in intestinal permeability after aspirin-induced intestinal barrier defects.
Each test will be performed after a 12h fast. Subjects will provide fasting blood and urine samples, fully empty their bladders and drink 50mL of water with/without soluble aspirin (650mg). After 30 min., subjects will drink 500mL of water or mixed meal beverage (22g protein, 26g fat, 52g carbs) with mannitol (2g) and lactulose (4g). A standardized snack and water (200mL) will be provided at 3h. Blood samples will be taken at 2h, 3h and 4h. All urine will be collected over 5 hours. Collection times were adapted to account for potential delays in gastric emptying (mixed meal vs. water). Lactulose-to-mannitol ratios, by HPAEC-PAD method, in urine and blood will be compared by phases using mixed linear models.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Water | No intervention | –Mannitol and lactulose diluted in water (500mL) |
| Mixed meal beverage | Placebo comparator | Dietary Supplement: Mixed meal beverageMannitol and lactulose diluted in mixed meal beverage (500mL) |
| Mixed meal beverage and aspirin | Experimental | Drug: Aspirin, Dietary Supplement: Mixed meal beverageAspirin (650mg) prior to mannitol and lactulose diluted in mixed meal beverage (500mL) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women
- 18-65y
- BMI <40
Key exclusion criteria (4 listed)
- Enteropathies
- Food intolerance or allergy related to the protocol
- Pregnancy or breastfeeding within the last 3 months
- Contraindications for aspirin - see Monograph
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 |
|---|---|---|
| AspirinAspirin 650mg prior mixed meal beverage | Drug | Mixed meal beverage and aspirin |
| Mixed meal beverageMixed meal beverage | Dietary supplement | Mixed meal beverage, Mixed meal beverage and aspirin |
Primary outcome
Intestinal permeability
Time frame: From baseline to hour 5
lactulose-to-mannitol ratio in urine
1 secondary outcome
Intestinal permeability
Time frame: At baseline, hour 2, hour 3 and hour 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Alain Veilleux, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin and Mixed meal beverage in people with Intestinal Permeability, run by Laval University at 1 site in Canada.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 25 Sep 2025. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intestinal permeability (time frame: From baseline to hour 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2025.