NCT06670807 · RECRUITING
Effect of a Probiotic Formula in Mild Cognitive Impairement
This trial tests whether a daily probiotic capsule, taken for 16 weeks, changes thinking and memory in people aged 60 to 85 with mild cognitive impairment. Researchers will compare it with a placebo and track brain scans, cognitive tests, blood markers, and gut bacteria. It has no formal phase, so it is an early nutrition study, not proof of benefit.
Eligibility criteria
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 antibiotics or probiotic supplements at least 3 months before the start of the study. * Subjects with hearing or visual impairments that prevent the evaluations included in the study * Subjects with severe illnesses affecting nutritional status (liver, kidney, etc.) * Subjects who have engaged in weight loss diets or significant dietary changes in the 8 weeks prior to starting the study * Subjects with high alcohol consumption (> 3 alcoholic beverages per day)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-07-16