The Symbiont-Restore Study (NCT05942586) | Clinical Trial Compass
CompletedNot Applicable
The Symbiont-Restore Study
Ireland137 participantsStarted 2023-05-22
Plain-language summary
Within the framework of the Science Foundation Ireland funded Microbe Restore Project, the Symbiont Restore Study is an Investigator-initiated trial which explores the prospective health advantages associated with a particular bacterium known as Limosilactobacillus reuteri (L. reuteri) PB-W1™.
In the Symbiont Restore Study, we seek to determine if supplementation with L. reuteri PB-W1™, can beneficially alter the composition and function of the gut microbiome, particularly in terms of immunomodulatory benefits, intestinal health, satiety, as well as markers of psychological stress and sleep quality. Additionally, this study will explore whether combining this strain with a prebiotic blend of dietary fibres (comprising 50 % raffinose and 50 % xylooligosaccharide) through a "synbiotic" approach can enhance its therapeutic benefits.
Who can participate
Age range
18 Years – 55 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:
* To be considered eligible for enrolment into the study, potential Participants must:
* Be able to give written informed consent.
* Be between 18 and 55 years of age.
* Self-identify as White.
* Have a BMI of 30-40 kg/m2 and waist circumference of ≥102cm (males) or ≥88cm (females).
* Have a stable body weight (≤5% change) over the past three months.
* Be in general good health, as determined by interview and having systolic blood pressure less than 160 mm Hg and diastolic blood pressure less than 100 mm Hg (defined as hypertension stage 2), taken by the investigator.
* Be willing to avoid consuming dietary supplements, prebiotics, probiotics, or fibre-rich supplements within four weeks prior to the baseline visit and until the end of the study.
* Be willing to maintain their current level of physical activity.
* Be willing to consume the investigational product daily for the duration of the study.
* Be willing to maintain their habitual diet for the duration of the study.
Exclusion Criteria:
* Potential Participants will be excluded from the study if they meet any of the below criteria:
* Are pregnant, lactating or post-menopausal or women who are planning to become pregnant over the study period.
* Have hypersensitivity, allergy, or intolerance to any of the components of the investigational products.
* Have received antibiotic treatment within three months prior to baseline.
* Are taking a medication that the investigato…
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 Immune Profile at 8 Weeks
Timeframe: The assessments will be conducted at baseline (pre-intervention) and at the end of the eight-week intervention period.