CP: Intestinal Permeability
ConditionIntestinal Permability
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRousselot BVBA
About this trial
The goal of this clinical trial is 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 it aims to answer is 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).
Eligibility criteria
Qualifiers
Be able to give written informed consent.
Be between 18-65 years (inclusive)
Gastrointestinal symptoms confirmed by an average GSRS-IBS score between ≥2.5 and ≤4.5 at Visit 1 and Visit 2 (+0.5).
If Participant has used aspirin in the past and they have not experienced adverse events.
Disqualifiers
Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
Sexual partner(s) is/are exclusively female.
Trial design
Treatments tested in this trial
- AP GUT collagen peptides
- Placebo
Treatment groups
92 Participants
are divided into 4 treatment groupsSponsors and collaborators
Rousselot BVBA
Lead sponsor
Atlantia Food Clinical Trials
Collaborator
Source ClinicalTrials.gov