- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07586930
CP: Intestinal Permeability
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Andrea Doolan
- Telefonní číslo: +353 21 430 7442
- E-mail: adoolan@atlantiatrials.com
Studijní místa
-
-
Ireland
-
Cork, Ireland, Irsko, T23 R50R
- Nábor
- Atlantia Clinical Trials
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Severe or uncontrolled cardiovascular disease
- Severe renal disease/ renal impairment
- Liver disease
- Diabetes
- Any known bleeding disorder
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:
- Medications affecting gut/intestinal motility (2 weeks prior to visit 1)
- 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
- Antibiotics (4 weeks prior to visit 1)
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:
- Collagen supplements (e.g., for bone and joint health and/or skin)
- Supplements effecting gut motility (e.g. iron, magnesium citrate)
- Cannabidiol or hemp containing products or supplements
- Probiotics
- Prebiotics
- Postbiotics
- 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.
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: Placebo produkt
|
Placebo
|
|
Experimentální: AP GUT collagen peptides 2.5 g
2.5 g AP GUT collagen peptides
|
AP GUT collagen peptides
|
|
Experimentální: AP GUT collagen peptides 5 g
5 g AP GUT collagen peptides
|
AP GUT collagen peptides
|
|
Experimentální: AP GUT collagen peptides 10 g
10 g AP GUT collagen peptides
|
AP GUT collagen peptides
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Intestinal permeability
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Intestinal permeability
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Occurrence of any Adverse Events (AEs/SAEs)
Časové okno: Baseline to Day 45
|
|
Baseline to Day 45
|
|
Composition of the gut microbiome
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- AFCRO-207
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .