CP: Intestinal Permeability

Официальное название

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.

Обзор

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).

Вмешательства

• Пищевая добавка AP GUT collagen peptides
  AP GUT collagen peptides
• Пищевая добавка Placebo
  Placebo

Первичные конечные точки

• Intestinal permeability [Срок оценки: Day 42 to Day 45]

Вторичные конечные точки (12)

• Intestinal permeability [Срок оценки: Day 42 to day 45]
• Intestinal permeability [Срок оценки: Day 42 to day 45]
• Gastrointestinal symptoms [Срок оценки: Day 42 to Day 45]
• Concentration of bacterial endotoxins [Срок оценки: Day 42 to Day 45]
• Concentration of intestinal permeability markers/ tight junction dysfunction Markers [Срок оценки: Day 42 to Day 45]
• Concentration of an intestinal damage marker [Срок оценки: Day 42 to Day 45]
• Concentration of cytokines [Срок оценки: Day 42 to Day 45]
• Concentration of an Inflammation marker [Срок оценки: Day 42 to Day 45]
• Quality of life Physical Component Summary [Срок оценки: Day 42 to Day 45]
• Quality of Life Mental Component Summary [Срок оценки: Day 42 to Day 45]
• Stress [Срок оценки: Day 42 to Day 45]
• Anxiety [Срок оценки: Day 42 to Day 45]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Ирландия · 1 центр

• Atlantia Clinical Trials — Cork

Идентификаторы

NCT: NCT07586930 · AFCRO-207

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗