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CP: Intestinal Permeability

22. Mai 2026 aktualisiert von: 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).

Studienübersicht

Studientyp

Interventionell

Einschreibung (Geschätzt)

92

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • Ireland
      • Cork, Ireland, Irland, T23 R50R
        • Rekrutierung
        • Atlantia Clinical Trials

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo-Produkt
Placebo
Experimental: AP GUT collagen peptides 2.5 g
2.5 g AP GUT collagen peptides
AP GUT collagen peptides
Experimental: AP GUT collagen peptides 5 g
5 g AP GUT collagen peptides
AP GUT collagen peptides
Experimental: AP GUT collagen peptides 10 g
10 g AP GUT collagen peptides
AP GUT collagen peptides

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intestinal permeability
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intestinal permeability
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Occurrence of any Adverse Events (AEs/SAEs)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

25. März 2026

Primärer Abschluss (Geschätzt)

2. November 2026

Studienabschluss (Geschätzt)

23. November 2026

Studienanmeldedaten

Zuerst eingereicht

8. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Mai 2026

Zuerst gepostet (Tatsächlich)

14. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • AFCRO-207

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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