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

A

Anahuac University

Status

Enrolling

Conditions

Cognitive Impairment

Treatments

Other: Placebo
Dietary Supplement: Enteroccocus Facieum and Agave Inulin

Study type

Interventional

Funder types

Other

Identifiers

NCT05688618
CEI-004-20160729

Details and patient eligibility

About

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.

Full description

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.

Cognitive impairment is the loss of cognitive functions, in the abscence of other pathologies that may be the cause of the memory loss. It is well known that this pathology can progress to more severe states reaching irreversible dementia such as Alzheimer in a short period of approximately 5 years from the onset of the disease.

Given the rapid increase in incidence of cognitive impairment, there have been several studies on the management of symptoms and on the natural course of the disease.

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.

The objective of this study is to evaluate the effect of the symbiotic on the cognitive process in senior adults.

To achieve this a clinical trial will be held in a senior citizen population who will be administered a symbiotic compound (enterococcus faecium and inulin) for 8 weeks and evaluated for cognitive functions using Mini-mental state examination, rey-osterrieth complex, and a validated tool (AeRAC).

The variables will be expressed as mean ± standard deviation, depending on the type of distribution of the data. It will be used paired T Student for homogenous data in an intragroup comparison or Wilcoxon test for heterogenous data. For intergroup comparison it will be used independent T Student for homogenous data and U Mann Whitney for dependent group in heterogenous data. Data analysis will be carried out using the latest version of GraphPad Prism.

Enrollment

48 estimated patients

Sex

All

Ages

70 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients with mild cognitive impairment
  • Patients who sign the informed consent

Exclusion criteria

  • 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

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

48 participants in 2 patient groups, including a placebo group

Experimental group
Active Comparator group
Treatment:
Dietary Supplement: Enteroccocus Facieum and Agave Inulin
Control group
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

ADELA ESCANDON CESARMAN, MEDICO CIRUJANO; JOSE JUAN ANTONIO IBARRA ARIAS, MEDICO CIRUJANO

Data sourced from clinicaltrials.gov

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