Effect of the Administration of a Symbiotic (E. Faecium and Agave Inulin) on Mild Cognitive Impairment in Older Adults
Primary Purpose
Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Enteroccocus Facieum and Agave Inulin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cognitive Impairment
Eligibility Criteria
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
Sites / Locations
- Hospital ABC Santa FeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Cognitive impairment
Change in Score for Mini mental state examination
Cognitive impairment
Change in Score for Rey-Osterrieth complex figure
Cognitive impairment
Change in Score for AeRAC (Instrumento de expectativas de autoeficacia)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05688618
Brief Title
Effect of the Administration of a Symbiotic (E. Faecium and Agave Inulin) on Mild Cognitive Impairment in Older Adults
Official Title
Effect of the Administration of a Symbiotic (E. Faecium and Agave Inulin) on Mild Cognitive Impairment in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
March 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anahuac University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Active Comparator
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Enteroccocus Facieum and Agave Inulin
Intervention Description
A pack of symbiotic powder with 1 gram of e. facieum and 8g of agave inulin will be administered daily for 8 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A pack of unsweetened almond powder milk will be administered daily for 8 weeks
Primary Outcome Measure Information:
Title
Cognitive impairment
Description
Change in Score for Mini mental state examination
Time Frame
8 weeks
Title
Cognitive impairment
Description
Change in Score for Rey-Osterrieth complex figure
Time Frame
8 weeks
Title
Cognitive impairment
Description
Change in Score for AeRAC (Instrumento de expectativas de autoeficacia)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JOSE JUAN ANTONIO IBARRA ARIAS, MEDICO CIRUJANO
Phone
5554197603
Email
jose.ibarra@anahuac.mx
First Name & Middle Initial & Last Name or Official Title & Degree
ADELA ESCANDON CESARMAN, MEDICO CIRUJANO
Phone
5520459938
Email
adela.escandon.cesarman@gmail.com
Facility Information:
Facility Name
Hospital ABC Santa Fe
City
Ciudad de Mexico
ZIP/Postal Code
05300
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adela Escandon-Cesarman, Medical degree
Phone
5520459938
Email
adela.escandon.cesarman@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
27719970
Citation
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Links:
URL
https://www.who.int/es/news-room/fact-sheets/detail/dementia
Description
Related Info
URL
https://doi.org/10.3389/fmicb.2018.01791
Description
Related Info
URL
http://www.conapo.gob.mx/work/models/CONAPO/Resource/1529/2/images/DocumentoMetodologicoProyecciones2010_2050.pdf
Description
Related Info
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://drive.google.com/drive/u/0/folders/1JG22lkEchQULxW79ktlsVcM5uGNB4iVh
Learn more about this trial
Effect of the Administration of a Symbiotic (E. Faecium and Agave Inulin) on Mild Cognitive Impairment in Older Adults
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