Synbiotic blend of LA-5 and agave inulin for mild cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a small, randomized, double-blind crossover trial in adults with mild cognitive impairment. Participants will receive a synbiotic containing Lactobacillus acidophilus LA-5 and agave inulin for 12 weeks, then switch to a control in almond powder after a 2-week washout, for another 12 weeks. Cognitive function will be measured with MoCA, M@T, and MMSE, while exploratory biomarkers related to the microbiota-gut-brain axis will be assessed in stool and blood. The study aims to explore whether the synbiotic can influence cognitive outcomes and gut-derived biomarkers in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Unidad de Especialidades Médicas de la Defensa (UEMD)
  Mexico City, Mexico City, Mexico Recruiting

Study contacts

• Study coordinator: Antonio Ibarra, PhD
• Email: jose.ibarra@anahuac.mx
• Phone: 52 55 54197603

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.