Prebiotic and Anti-inflammatory Effects of a Pectin Polysaccharide (NCT05421793) | Clinical Trial Compass
CompletedNot Applicable
Prebiotic and Anti-inflammatory Effects of a Pectin Polysaccharide
Sweden17 participantsStarted 2022-06-06
Plain-language summary
The aim of this study is to determine, quantify and understand the potential prebiotic and anti-inflammatory effects of the pecticpolysaccharide rhamnogalacturonan I (RG-I). The effects of these dietary fibre fractions on barrier function will also be investigated.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed consent prior to any study related procedures
. Age 18-65 years
. Willing to abstain from regular consumption of prebiotics/probiotics products or medication known to alter gastrointestinal functions at least 4 weeks prior to the study visits
Exclusion criteria
. Previous complicated gastrointestinal surgery
. Presence of gastrointestinal disorder or any disorder which the principal investigator considers to affect the results of the study
. Current diagnosis of psychiatric disease
. Current and past diagnosis inflammatory gastrointestinal disease (e.g. Irritable Bowel Disease)
. Systemic use of antibiotics or steroids medications in the last 3 months
. Frequent use of NSAID (Non Steroidal Anti Inflammatory Drugs) the last 2 months prior to study visits
. Regular consumption of prebiotic/probiotic products for the past 4 weeks
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline of barrier function after 90 minutes of ex vivo stimulation of the colonic biopsies.
Timeframe: Barrier function will be measured at baseline and after 90 minutes of ex vivo stimulation of the colonic biopsies.
2
Change from baseline to the effect on the intestinal microbial populations and their metabolic products [i.e. Short-Chain Fatty Acids (SCFA)] (prebiotic effect) by the end of the in vitro fermentation process.
Timeframe: The levels of microbial populations and their metabolic products will be measured at baseline and after 6 hours of in vitro fermentation procedure.