Effect of the Administration of a Symbiotic (E. Faecium and Agave Inulin) on Mild Cognitive Impairment in Older Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70-85
SponsorAnahuac University

About this trial

Cognitive impairment is one of the fastest growing diseases in the last decades, given the significant increase in senior citizen population in Mexico and the world.

Several studies have discussed the gut-microbiota-brain axis. It has been demonstrated that a balanced gut microbiota, prevents an increase in pro-inflammatory cytokines that affect specific brain areas; having an important impact at the cortical level of the hippocampus which translates to diminished cognitive function and the start of cognitive impairment symptoms.

After multiple studies on the effect of the administration of symbiotics in animal models in cognition and memory, there have been positive results, observing improvement in cognition and decrement in inflammatory cytokines at hippocampus level.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with mild cognitive impairment

Patients who sign the informed consent

Disqualifiers

Patients who do not have mild cognitive impairment

Patients with advanced cognitive impairment such as Alzheimers disease

Patients with comorbidities that influence the cognitive functions such as diabetes mellitus, cerebral ischemia or previous brain trauma

Patients who do not sign the informed consent

Trial design

Design model

Crossover

Treatments tested in this trial

  • Enteroccocus Facieum and Agave Inulin

    Dietary supplement

    A pack of symbiotic powder with 1 gram of e. facieum and 8g of agave inulin will be administered daily for 8 weeks

  • Placebo

    Other intervention

    A pack of unsweetened almond powder milk will be administered daily for 8 weeks

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Experimental groupActive comparator 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cognitive impairment

Change in Score for Mini mental state examination

Time frame
8 weeks
2

Cognitive impairment

Change in Score for Rey-Osterrieth complex figure

Time frame
8 weeks
3

Cognitive impairment

Change in Score for AeRAC (Instrumento de expectativas de autoeficacia)

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.