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New treatment option for Intestinal Permability
Official title CP: Intestinal Permeability
ClinicalTrials.gov ID: NCT07586930
What this study is testing
- What it's testing
- 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).
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join 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.
You likely can't join 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...
- 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...
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Cork, Ireland, Ireland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cork, Ireland, Ireland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.