Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT07586930

CP: Intestinal Permeability

Led by Rousselot BVBA · Updated on 2026-05-14

92

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

Sponsors

R

Rousselot BVBA

Lead Sponsor

A

Atlantia Food Clinical Trials

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to to evaluate the effects of 45 days daily administration of three different doses (2.5g, 5g, and 10g) of collagen peptide in healthy adults as compared to a Placebo on intestinal permeability following an acute aspirin challenge. The main question\[s\] it aims to answer Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide respectively as compared to a Placebo on intestinal permeability measured by the urinary lactulose : mannitol ratio (test collected over a period of 5 hours). Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

CONDITIONS

Official Title

CP: Intestinal Permeability

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide written informed consent
  • Aged between 18 and 65 years inclusive
  • Moderate gastrointestinal symptoms with average GSRS-IBS score between 2.5 and 4.5 at screening visits
  • Past aspirin use without adverse events
  • Willing to avoid alcohol 2 days before each permeability test
  • Willing to avoid lactulose, sugar substitutes, sucralose, or mannitol-containing products 24 hours before urine collection
  • Willing to consume the study product daily during the study
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or planning pregnancy during the study
  • Biological childbearing potential without continuous effective contraception
  • DASS-21 Depression score over 21 at screening
  • History of drug or alcohol abuse exceeding national recommendations
  • Food allergies or issues preventing intake of study products
  • Lactose intolerance
  • Vegetarian unwilling to consume animal-based supplements
  • Intolerance to aspirin
  • Significant acute or chronic health conditions preventing study participation or confounding results, including diagnosed gastrointestinal conditions, severe cardiovascular disease, severe kidney disease, liver disease, diabetes, or bleeding disorders
  • Current or recent use of medications interfering with study, including gut motility medications, regular NSAIDs use within 2 months, or antibiotics within 4 weeks
  • Current or recent use of nutritional or non-nutritional supplements interfering with study, including collagen supplements, gut motility affecting supplements, cannabidiol/hemp products, probiotics, prebiotics, or postbiotics
  • Considered unlikely to comply with study or poor attendance
  • Participation in other clinical studies without sufficient washout period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Atlantia Clinical Trials

Cork, Ireland, Ireland, T23 R50R

Actively Recruiting

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Research Team

A

Andrea Doolan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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CP: Intestinal Permeability | DecenTrialz