Intestinal Permeability Test for Leaky Gut Syndrome

(Gut-Perm Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: Enteropathies, Food intolerance, Pregnancy, others

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a test to measure how easily substances pass through the gut, potentially aiding in the understanding of "leaky gut syndrome." Participants will consume drinks containing specific sugars, with some groups also taking aspirin, to observe effects on gut permeability. The study seeks men and women with a BMI under 40 who do not have certain digestive issues or food allergies. As an unphased trial, participants can contribute to groundbreaking research that may enhance the understanding and treatment of gut health issues.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications.

What prior data suggests that the Meal-provoked Intestinal Permeability Test is safe?

Research has shown that taking aspirin with a meal-based test can impact gut health. Studies have found that even short-term aspirin use can make the gut lining more "leaky," allowing substances to pass through more easily than normal.

A single dose of aspirin, known as an acute aspirin challenge, increased this leakiness. Several studies have observed this effect, indicating that aspirin can affect the gut barrier. However, this change is expected during the test and is usually well-tolerated for short-term use. It is important to note that larger doses or long-term aspirin use could lead to more serious gut issues.

In general, using aspirin for a short time in this test is considered safe, but consulting a healthcare provider is advisable if there are any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to better understand leaky gut syndrome by using a meal-provoked intestinal permeability test, which is a novel approach. Unlike traditional tests that often require invasive procedures, this method uses mannitol and lactulose diluted in beverages to non-invasively assess gut permeability. Additionally, one arm of the trial explores the effect of aspirin on gut permeability, which could reveal important insights into how different substances affect gut health. By refining our understanding of intestinal permeability, this trial could lead to more accurate diagnoses and potentially inform new treatments for leaky gut syndrome.

What evidence suggests that the Meal-provoked Intestinal Permeability Test is effective for assessing leaky gut syndrome?

Research has shown that aspirin can make the gut lining more "leaky," allowing more substances to pass through than normal. One study found that taking aspirin increased this leakiness. Another study suggested that aspirin might disrupt the balance of bacteria in the gut, potentially affecting gut health. In this trial, one treatment arm involves administering aspirin before a meal-provoked intestinal permeability test to study how substances pass through the gut lining. These findings indicate that aspirin can influence the gut, making it useful for such tests. ^{1 2 3 5 6}

Who Is on the Research Team?

Alain Veilleux, PhD

Principal Investigator

Laval University

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-65 with a BMI under 40, who do not have food intolerances or allergies related to the study protocol. Participants should not be pregnant or breastfeeding in the last three months, have no history of gut diseases (enteropathies), and must be able to safely take aspirin.

Inclusion Criteria

BMI less than 40

I am either a man or a woman.

I am between 18 and 65 years old.

Exclusion Criteria

Food intolerance or allergy related to the protocol

Pregnancy or breastfeeding within the last 3 months

I have a history of intestinal problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intestinal Permeability Testing

Participants undergo three intestinal permeability tests: fasting, meal-provoked, and meal-provoked with acute aspirin challenge.

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the tests

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Meal-provoked Intestinal Permeability Test

Trial Overview The trial is testing how a mixed meal beverage affects intestinal permeability, also known as 'leaky gut syndrome', when taken with aspirin. The goal is to develop reliable tests that can assess nutritional and metabolic health by observing changes after a meal.

How Is the Trial Designed?

Group I: Mixed meal beverage and aspirin Experimental Treatment 2 Interventions

Aspirin (650mg) prior to mannitol and lactulose diluted in mixed meal beverage (500mL)

Group II: Water Active Control 1 Intervention

Mannitol and lactulose diluted in water (500mL)

Group III: Mixed meal beverage Placebo Group 1 Intervention

Mannitol and lactulose diluted in mixed meal beverage (500mL)

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Citations

1. mdpi.com mdpi.com/1422-0067/25/6/3424

Aspirin Caused Intestinal Damage through FXR and ET-1 ... The study revealed the key roles of the FXR and ET-1 pathways in acute and chronic aspirin-induced intestinal injuries.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10759586/

The effect of an acute aspirin challenge on intestinal ... This study investigates the effects of an acute aspirin challenge on gastroduodenal barrier function with or without prophylactic probiotic consumption.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1931312823005103

Article A gut microbiota-bile acid axis promotes intestinal ... Together, these data suggest that aspirin impairs gut barrier function, potentially through inducing gut dysbiosis and suppressing P. goldsteinii. Aspirin ...

4. researchgate.net researchgate.net/publication/356391317_An_Observational_Study_to_Evaluate_the_Association_between_Intestinal_Permeability_Leaky_Gut_Related_Markers_and_Metabolic_Health_in_Healthy_Adults

(PDF) An Observational Study to Evaluate the Association ... The test was performed with/without an acetylsalicylic acid challenge to measure and correlate the gut permeability, LGM, and metabolic health.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38166769/

The effect of an acute aspirin challenge on intestinal ... Conclusion: The acute aspirin challenge significantly increased intestinal permeability similarly in both groups, and prophylactic probiotic ...

6. tandfonline.com tandfonline.com/doi/full/10.2147/DDDT.S493049

Enteric-Coated Aspirin Induces Small Intestinal Injury via ... These findings suggest that aspirin increases intestinal permeability via superoxide-mediated tight junction disruption, triggering localized intestinal ...