CP: Intestinal Permeability
ConditionIntestinal Permability
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRousselot BVBA
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
AP GUT collagen peptides
Dietary supplementAP GUT collagen peptides
Placebo
Dietary supplementPlacebo
Treatment groups
92 Participants
are divided into 4 treatment groupsGroup A: AP GUT collagen peptides 2.5 gExperimental treatment 1 intervention
Group B: AP GUT collagen peptides 5 gExperimental treatment 1 intervention
Group C: AP GUT collagen peptides 10 gExperimental treatment 1 intervention
Group D: Placebo ProductPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intestinal permeability
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
Time frame
Day 42 to Day 45Secondary outcomes
1
Intestinal permeability
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
Time frame
Day 42 to day 452
Intestinal permeability
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
Time frame
Day 42 to day 453
Gastrointestinal symptoms
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.
Time frame
Day 42 to Day 454
Concentration of bacterial endotoxins
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))
Time frame
Day 42 to Day 45Other outcomes
1
Composition of the gut microbiome
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
Time frame
Baseline to Day 452
Concentration of plasma GLP-2
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
Time frame
Baseline to Day 453
Occurrence of any Adverse Events (AEs/SAEs)
* 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.
Time frame
Baseline to Day 45Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rousselot BVBA
Lead sponsor
Atlantia Food Clinical Trials
Collaborator
Source ClinicalTrials.gov