Effect of a Probiotic Formula in Mild Cognitive Impairement (NCT06670807) | Clinical Trial Compass
RecruitingNot Applicable
Effect of a Probiotic Formula in Mild Cognitive Impairement
Spain100 participantsStarted 2026-03-21
Plain-language summary
Mild cognitive impairment is currently one of the most relevant social challenges, as its prevalence is expected to increase and it is associated with a higher risk of developing Alzheimer's disease or other types of dementia. Therefore, it is necessary to seek strategies that can be applied in the early stages to delay or reverse the progression of the disease.
In this context, probiotics have emerged as a promising alternative for managing cognitive disorders. This project is a clinical-nutritional trial to evaluate the utility of consuming a dietary supplement containing probiotics on the cognitive function of individuals with mild cognitive impairment. The study will involve 100 participants, selected from the Geriatrics Unit of San Carlos Clinical Hospital, as well as through various Leisure Centers in Madrid, randomly assigned to two groups of 50 individuals each (Experimental Group and Control Group). Participants assigned to the experimental group will consume the dietary supplement, while those in the control group will receive a placebo, which is a product without probiotics. Both groups will take 1 capsule per day of the assigned product at breakfast for 16 weeks. During this time, changes will be analyzed in various imaging tests, cognitive tests, and some blood parameters related to cognitive function. Changes in gut microbiota and different lifestyle factors (diet, body composition, physical activity, sleep) will also be evaluated.
Who can participate
Age range
65 Years – 85 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:
* Men and women aged between 60 and 85 years.
* Present "Mild Cognitive Impairment" (MCI) based on:
* MoCA test (\< 26 points) or score adjusted for educational level
* and CDR test (≤ 0.5 points)
* Maintain functional capacity according to the (I)ADL test (≥ 70 points)
* Show "cognitive concern" reported by the participant and/or a surrogate caregiver
* Demonstrate longitudinal decline in cognitive function (progressive and not stabilized) for more than 3-5 years.
* BMI ≥ 20 and \< 30 kg/m²
* Absence of a family or social environment that prevents treatment adherence.
* Adequate cultural level and understanding of the clinical study.
* Agree to participate voluntarily in the study and provide written informed consent.
Exclusion Criteria:
* Subjects with severe neurological or psychiatric disorders due to any of the following causes: severe dementia, depression, epilepsy, schizophrenia, or bipolar disorder.
* Subjects who have suffered a severe stroke prior to the study (FAZKAS=3)
* Subjects with a history of malignancy \< 5 years (\< 5 years if the brain was affected)
* Subjects who have experienced severe traumatic brain injury with structural brain injury and/or prior brain surgery
* Subjects with pacemakers and those with metal implants that may interfere with EEG or MRI
* Subjects treated with medications: benzodiazepines, neuroleptics, narcotics, anticonvulsants, or sedative-hypnotics in the last 3 months
* Subjects who have been treated with anti…
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 in cognitive function by electrophysiological study
Timeframe: From enrollment to the end of treatment at 16 weeks