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NCT Number: NCT05688618

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

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.

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Key information

Age range

70 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital ABC Santa Fe

Mexico City, 05300, Mexico

Location status: Recruiting

Location contact

Adela Escandon-Cesarman, Medical degree

CONTACT

[email protected]

5520459938

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Cognitive impairment

    Time frame: 8 weeks

    Change in Score for Mini mental state examination

  2. Cognitive impairment

    Time frame: 8 weeks

    Change in Score for Rey-Osterrieth complex figure

  3. Cognitive impairment

    Time frame: 8 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

ADELA ESCANDON CESARMAN, MEDICO CIRUJANO

CONTACT

[email protected]

5520459938

JOSE JUAN ANTONIO IBARRA ARIAS, MEDICO CIRUJANO

CONTACT

[email protected]

5554197603

Sponsors and collaborators

Lead sponsor

Anahuac University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2023
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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