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CP: Intestinal Permeability

22 mai 2026 mis à jour par: Rousselot BVBA

Effects of Collagen Peptide on Intestinal Permeability Following an Acute Aspirin Challenge in Adults With Moderate GI Symptoms: a Double-blind, Placebo-controlled, Randomised Study.

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).

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Estimé)

92

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

    • Ireland
      • Cork, Ireland, Irlande, T23 R50R
        • Recrutement
        • Atlantia Clinical Trials

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

Inclusion Criteria:

  1. Be able to give written informed consent.
  2. Be between 18-65 years (inclusive)
  3. Gastrointestinal symptoms confirmed by an average GSRS-IBS score between ≥2.5 and ≤4.5 at Visit 1 and Visit 2 (+0.5).
  4. If Participant has used aspirin in the past and they have not experienced adverse events.
  5. Willing to avoid alcohol consumption 2 days prior to each permeability test.
  6. Willing to refrain from lactulose, sugar substitutes, and sucralose or mannitol-containing products, for 24-hours prior to the urine collection period.
  7. Willing to consume the study product daily for the duration of the study.

Exclusion Criteria:

  1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
  2. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:

    1. 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).
    2. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
    3. Sexual partner(s) is/are exclusively female.
    4. 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.
    5. 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.
  3. DASS-21 Depression score of >21 at screening.
  4. 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).
  5. Has food allergies or other issues with foods that would preclude intake of the Study Products
  6. Lactose intolerance
  7. Vegetarians not willing to consume animal-based food supplement.
  8. Intolerant to aspirin.
  9. 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:

    1. Diagnosed gastrointestinal condition
    2. Severe or uncontrolled cardiovascular disease
    3. Severe renal disease/ renal impairment
    4. Liver disease
    5. Diabetes
    6. Any known bleeding disorder
  10. Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:

    1. Medications affecting gut/intestinal motility (2 weeks prior to visit 1)
    2. Daily usage of non-steroidal anti-inflammatory drugs (NSAIDs) in the last 2 months or incidental use in the last 2 weeks prior to screening
    3. Antibiotics (4 weeks prior to visit 1)
  11. Current or recent (in the past 4-weeks) use of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited supplements include:

    1. Collagen supplements (e.g., for bone and joint health and/or skin)
    2. Supplements effecting gut motility (e.g. iron, magnesium citrate)
    3. Cannabidiol or hemp containing products or supplements
    4. Probiotics
    5. Prebiotics
    6. Postbiotics
  12. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
  13. Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Produit placebo
Placebo
Expérimental: AP GUT collagen peptides 2.5 g
2.5 g AP GUT collagen peptides
AP GUT collagen peptides
Expérimental: AP GUT collagen peptides 5 g
5 g AP GUT collagen peptides
AP GUT collagen peptides
Expérimental: AP GUT collagen peptides 10 g
10 g AP GUT collagen peptides
AP GUT collagen peptides

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Intestinal permeability
Délai: Day 42 to Day 45
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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Intestinal permeability
Délai: Day 42 to day 45
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 as compared to a Placebo on intestinal permeability as measured by 5h % urinary lactulose excretion
Day 42 to day 45
Intestinal permeability
Délai: Day 42 to day 45
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 as compared to a Placebo on intestinal permeability as measured by 5h % urinary mannitol excretion
Day 42 to day 45
Intestinal permeability
Délai: Baseline to Day 42
Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on intestinal permeability as measured by Lactulose:Mannitol ratio
Baseline to Day 42
Intestinal permeability
Délai: Baseline to Day 42
Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on intestinal permeability as measured by 5h % urinary mannitol excretion
Baseline to Day 42
Gastrointestinal symptoms
Délai: Baseline to Day 42
Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo as measured by Gastrointestinal symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS) -Irritable Bowel Syndrome (IBS) Total score.
Baseline to Day 42
Gastrointestinal symptoms
Délai: Day 42 to Day 45
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 as compared to a Placebo as measured by Gastrointestinal symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS) -Irritable Bowel Syndrome (IBS) Total score. The GSRS-IBS questionnaire includes 13 items that measure the severity of IBS symptoms in five clusters (pain, bloating, constipation, diarrhea and early satiety) during the last seven days. A decrease is desirable.
Day 42 to Day 45
Concentration of bacterial endotoxins
Délai: Day 42 to Day 45
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 as compared to a Placebo on Bacterial endotoxins (LPS-binding protein (LBP))
Day 42 to Day 45
Concentration of intestinal permeability markers/ tight junction dysfunction Markers
Délai: Day 42 to Day 45
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 as compared to a Placebo on Intestinal permeability markers (Occludin, Zonulin)
Day 42 to Day 45
Concentration of an intestinal damage marker
Délai: Day 42 to Day 45
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 as compared to a Placebo on Intestinal damage markers (Intestinal fatty acid binding protein (I-FABP))
Day 42 to Day 45
Concentration of cytokines
Délai: Day 42 to Day 45
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 as compared to a Placebo on Cytokines (TNFa, IFNg, IL6, IL1b, IL17 and IL10)
Day 42 to Day 45
Concentration of an Inflammation marker
Délai: Day 42 to Day 45
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 as compared to a Placebo on Inflammation marker (Calprotectin)
Day 42 to Day 45
Quality of life Physical Component Summary
Délai: Day 42 to Day 45
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 as compared to a Placebo on Quality of life as assessed by SF-12 Physical Component Summary Score, The Short Form 12 Health Survey (SF-12) produces Component Summary scores using norm-based scoring (mean 50, standard deviation 10), with higher scores indicating better health-related quality of life.
Day 42 to Day 45
Quality of Life Mental Component Summary
Délai: Day 42 to Day 45
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 as compared to a Placebo on Quality of life as assessed by SF-12 Mental Component Summary Score, The Short Form 12 Health Survey (SF-12) produces Component Summary scores using norm-based scoring (mean 50, standard deviation 10), with higher scores indicating better health-related quality of life.
Day 42 to Day 45
Stress
Délai: Day 42 to Day 45
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 as compared to a Placebo on Stress as assessed by DASS-21 - Stress scores. The Depression Anxiety Stress Scales-21 (DASS-21) produces subscale scores based on summed item responses on a 4-point Likert scale (0-3), with higher scores indicating greater severity of symptoms.
Day 42 to Day 45
Anxiety
Délai: Day 42 to Day 45
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 as compared to a Placebo on Anxiety as assessed by DASS-21 - Anxiety scores. The Depression Anxiety Stress Scales-21 (DASS-21) produces subscale scores based on summed item responses on a 4-point Likert scale (0-3), with higher scores indicating greater severity of symptoms.
Day 42 to Day 45
Percentage urinary lactulose excretion
Délai: Baseline to Day 42
Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on intestinal permeability as measured by 5h % urinary lactulose excretion
Baseline to Day 42
Concentration of bacterial endotoxins
Délai: Baseline to Day 42
Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Bacterial endotoxins (LPS-binding protein (LBP))
Baseline to Day 42
Concentration of intestinal permeability markers
Délai: Baseline to Day 42
Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Intestinal permeability markers (Occludin, Zonulin)
Baseline to Day 42
Concentration if intestinal damage marker
Délai: Baseline to Day 42
Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Intestinal damage markers (Intestinal fatty acid binding protein (I-FABP))
Baseline to Day 42
Concentration of Cytokines
Délai: Baseline to Day 42
Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Cytokines (TNFa, IFNg, IL6, IL1b, IL17 and IL10)
Baseline to Day 42
Concentration of an inflammation marker
Délai: Baseline to Day 42
Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Inflammation marker (Calprotectin)
Baseline to Day 42
Quality of life as assessed by SF-12- Physical Component Summary
Délai: Baseline to Day 42
Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Quality of life as assessed by SF-12 PCS (Physical Component Summary). The Short Form 12 Health Survey (SF-12) produces Component Summary scores using norm-based scoring (mean 50, standard deviation 10), with higher scores indicating better health-related quality of life.
Baseline to Day 42
Quality of life - Mental Component Summary
Délai: Baseline to Day 42
Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Quality of life as assessed by SF-12 MCS (Mental Component Summary). The Short Form 12 Health Survey (SF-12) produces Component Summary scores using norm-based scoring (mean 50, standard deviation 10), with higher scores indicating better health-related quality of life.
Baseline to Day 42
Stress
Délai: Baseline to Day 42
Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Stress as assessed by DASS-21 - Stress scores. The Depression Anxiety Stress Scales-21 (DASS-21) produces subscale scores based on summed item responses on a 4-point Likert scale (0-3), with higher scores indicating greater severity of symptoms.
Baseline to Day 42
Anxiety
Délai: Baseline to Day 42
Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on anxiety as assessed by DASS-21 - Anxiety scores. The Depression Anxiety Stress Scales-21 (DASS-21) produces subscale scores based on summed item responses on a 4-point Likert scale (0-3), with higher scores indicating greater severity of symptoms
Baseline to Day 42

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Occurrence of any Adverse Events (AEs/SAEs)
Délai: Baseline to Day 45
  • Incidence of AEs per group by product causality.
  • Incidence of mild, moderate, and severe AEs per group by product causality.
  • Incidence of AEs by MedDRA System Organ Classification (SOC) and preferred term (PT) by product allocation.
  • Incidence of SAEs per group by product causality.
Baseline to Day 45
Composition of the gut microbiome
Délai: Baseline to Day 45
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 Gut microbiome
Baseline to Day 45
Concentration of plasma GLP-2
Délai: Baseline to Day 45
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 Plasma GLP-2
Baseline to Day 45

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

25 mars 2026

Achèvement primaire (Estimé)

2 novembre 2026

Achèvement de l'étude (Estimé)

23 novembre 2026

Dates d'inscription aux études

Première soumission

8 mai 2026

Première soumission répondant aux critères de contrôle qualité

8 mai 2026

Première publication (Réel)

14 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • AFCRO-207

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be shared due to confidentiality, participant consent limitations, and data protection requirements.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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