NCT07818369 · RECRUITING
Synbiotic LA-5 and Agave Inulin for Mild Cognitive Impairment
This small crossover study tests a daily probiotic-fiber combo (L. acidophilus LA-5 plus agave inulin) in adults 60-75 with mild cognitive impairment, to see if it improves memory test scores and shifts gut bacteria, inflammation markers, and BDNF levels. It's an early pilot study — 40 people, 12 weeks per arm — meant to check for a signal, not to prove benefit.
Eligibility criteria
Inclusion Criteria: * Adults aged 60 to 75 years. * Presence of mild cognitive impairment (MCI) determined by neuropsychological testing, meeting at least two of the following three established cutoff criteria: * Montreal Cognitive Assessment (MoCA): 19-26 points. * Memory Alteration Test (M@T): 28-37 points. * Mini-Mental State Examination (MMSE): 12-24 points. * Ability and willingness to provide written informed consent; consent may be provided by a family member or legal representative when necessary. Exclusion Criteria: * Previous diagnosis of severe cognitive impairment, Alzheimer disease, vascular dementia, or another neurodegenerative disorder affecting cognition. * History of cerebral ischemia, cerebrovascular events, traumatic brain injury, or advanced-stage renal disease. * Diagnosis of type 2 diabetes mellitus. * Diagnosed dysbiosis or inflammatory bowel disease, including ulcerative colitis or Crohn disease. * Use of antibiotics, laxatives, probiotics, or prebiotics within the 3 months prior to enrollment. * Habitual consumption of fermented foods or fiber-rich supplements, particularly fiber intake >18 g/day. * Excessive alcohol consumption, defined as ≥2 alcoholic drinks per day, or history of alcohol dependence. * Chronic use of medications that may interfere with the microbiota-gut-brain axis, including immunosuppressants, antipsychotics, or corticosteroids. * Recent surgery within the previous 3 months or a planned medical intervention during the study period. * Known adverse reaction or hypersensitivity to any component of the synbiotic or to almond powder. * Uncontrolled chronic stress identified by clinical assessment. * Participation in intense physical activity or high-performance sports during the study.
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 2026-09-14