Microbiome-Targeted Enhancement of Neurocognition With Probiotics-Riboflavin Combination (NCT07410052) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Microbiome-Targeted Enhancement of Neurocognition With Probiotics-Riboflavin Combination
28 participantsStarted 2026-04-15
Plain-language summary
This randomized, double-blind, placebo-controlled trial will evaluate whether 12 weeks of supplementation with the probiotic Lactobacillus rhamnosus GG combined with colon-delivered riboflavin will improve cognitive performance and brain physiology in older adults with memory complaints. The study will assess changes in cognitive outcomes together with neurophysiological markers to explore potential gut-brain axis mechanisms. Through its rigorous design, the trial will aim to determine whether targeted modulation of the intestinal environment can support brain function and cognitive health in aging.
Who can participate
Age range
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:
* Age \> 65 years
* MoCA scores 18-25 points
* BMI of 20.0 - 29.9 kg/m2 at screening
* Stable body weight (≤ 5% change) over the past 3-months
* Willing to avoid consuming gut microbiome-modulating dietary supplements within 4 weeks prior to the baseline visit
* Subjects will abstain from vitamin B2-rich food intake as per pre-defined list
* Maintain current level of physical activity
* Be willing and able to comply with trial protocol
Exclusion Criteria:
* Severe chronic disease and acute injuries
* History of dietary supplement use four weeks before enrolment
* Organic gastrointestinal (GI) disorders
* Bowel surgery or short bowel syndrome
* Gut-altering medications two months before enrolment
* Is currently using systemic steroids, proton pump inhibitors, H2 blocker, antacid
* History of drug and/or alcohol abuse at the time of enrolment
* Smoker or vaper
* Has made any major dietary changes in the past 3 months prior to baseline
* Has a currently active eating disorder
* Has food allergies or other issues with foods
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
Montreal Cognitive Assesment scores
Timeframe: Change from baseline The Montreal Cognitive Assessment (MoCA) score at 12 weeks