CP: Intestinal Permeability

NCT07586930 | Recruiting

• 1 other identifier: AFCRO-207
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Intestinal Permability

Keywords

intestinal permability

Outcome Measures

Primary Outcomes (1)

• Intestinal permeability

  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

  Day 42 to Day 45

Secondary Outcomes (25)

• Intestinal permeability

  Day 42 to day 45

• Intestinal permeability

  Day 42 to day 45

• Gastrointestinal symptoms

  Day 42 to Day 45

• Bacterial endotoxins

  42 to Day 45

• Intestinal permeability markers/ Tight Junction Dysfunction Markers

  42 to Day 45

Other Outcomes (3)

• Gut microbiome

  Baseline to Day 45

• Plasma GLP-2

  Baseline to Day 45

• Occurrence of any Adverse Events (AEs/SAEs)

  Baseline to Day 45

Study Arms (4)

AP GUT collagen peptides 2.5 g

EXPERIMENTAL

2.5 g AP GUT collagen peptides

Dietary Supplement: AP GUT collagen peptides

AP GUT collagen peptides 5 g

EXPERIMENTAL

5 g AP GUT collagen peptides

Dietary Supplement: AP GUT collagen peptides

AP GUT collagen peptides 10 g

EXPERIMENTAL

10 g AP GUT collagen peptides

Dietary Supplement: AP GUT collagen peptides

Placebo Product

PLACEBO COMPARATOR

Placebo Product

Dietary Supplement: Placebo

Interventions

AP GUT collagen peptides DIETARY_SUPPLEMENT

AP GUT collagen peptides

AP GUT collagen peptides 10 g; AP GUT collagen peptides 2.5 g; AP GUT collagen peptides 5 g

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo Product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willing to avoid alcohol consumption 2 days prior to each permeability test.
• Willing to refrain from lactulose, sugar substitutes, and sucralose or mannitol-containing products, for 24-hours prior to the urine collection period.
• Willing to consume the study product daily for the duration of the study.

You may not qualify if:

• Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
• Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
• 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.
• Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.
• Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.
• DASS-21 Depression score of \>21 at screening.
• Has a history of drug and/or alcohol abuse. (Drinks more than nationally recommended units per week (\>11 units for women; \>17 units for men); alcohol/substance abuse disorder).
• Has food allergies or other issues with foods that would preclude intake of the Study Products
• Lactose intolerance
• Vegetarians not willing to consume animal-based food supplement.
• Intolerant to aspirin.
• Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:
• Diagnosed gastrointestinal condition

Sponsors & Collaborators

• Rousselot BVBA: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Clinical Trials

Cork, Ireland, T23 R50R, Ireland

RECRUITING

Central Study Contacts

Andrea Doolan

CONTACT

+353 21 430 7442; adoolan@atlantiatrials.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): November 2, 2026
• Study Completion (Estimated): November 23, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)