NCT05688618

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 16, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

August 19, 2022

Last Update Submit

July 29, 2024

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

  • Cognitive impairment

    Change in Score for Mini mental state examination

    8 weeks

  • Cognitive impairment

    Change in Score for Rey-Osterrieth complex figure

    8 weeks

  • Cognitive impairment

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

    8 weeks

Study Arms (2)

Experimental group

ACTIVE COMPARATOR
Dietary Supplement: Enteroccocus Facieum and Agave Inulin

Control group

PLACEBO COMPARATOR
Other: Placebo

Interventions

Enteroccocus Facieum and Agave InulinDIETARY_SUPPLEMENT

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

Experimental group
PlaceboOTHER

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

Control group

Eligibility Criteria

Age70 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital ABC Santa Fe

Mexico City, 05300, Mexico

RECRUITING

Related Publications (19)

  • Borras Blasco C, Vina Ribes J. [Neurophysiology and ageing. Definition and pathophysiological foundations of cognitive impairment]. Rev Esp Geriatr Gerontol. 2016 Jun;51 Suppl 1:3-6. doi: 10.1016/S0211-139X(16)30136-6. Spanish.

    PMID: 27719970BACKGROUND

  • Benavides-Caro, C. Deterioro cognitivo en el adulto mayor. Medigraphic, (2017). 40(2).

    BACKGROUND

  • Romo-Araiza A, Gutierrez-Salmean G, Galvan EJ, Hernandez-Frausto M, Herrera-Lopez G, Romo-Parra H, Garcia-Contreras V, Fernandez-Presas AM, Jasso-Chavez R, Borlongan CV, Ibarra A. Probiotics and Prebiotics as a Therapeutic Strategy to Improve Memory in a Model of Middle-Aged Rats. Front Aging Neurosci. 2018 Dec 18;10:416. doi: 10.3389/fnagi.2018.00416. eCollection 2018.

    PMID: 30618722BACKGROUND

  • Landefeld, C. Current geriatric diagnosis & treatment. New York: McGraw-Hill Professional. (2004).

    BACKGROUND

  • Lin JS, O'Connor E, Rossom RC, Perdue LA, Eckstrom E. Screening for cognitive impairment in older adults: A systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013 Nov 5;159(9):601-12. doi: 10.7326/0003-4819-159-9-201311050-00730.

    PMID: 24145578BACKGROUND

  • Grammas P. Neurovascular dysfunction, inflammation and endothelial activation: implications for the pathogenesis of Alzheimer's disease. J Neuroinflammation. 2011 Mar 25;8:26. doi: 10.1186/1742-2094-8-26.

    PMID: 21439035BACKGROUND

  • Ticinesi A, Tana C, Nouvenne A, Prati B, Lauretani F, Meschi T. Gut microbiota, cognitive frailty and dementia in older individuals: a systematic review. Clin Interv Aging. 2018 Aug 29;13:1497-1511. doi: 10.2147/CIA.S139163. eCollection 2018.

    PMID: 30214170BACKGROUND

  • Novotny M, Klimova B, Valis M. Microbiome and Cognitive Impairment: Can Any Diets Influence Learning Processes in a Positive Way? Front Aging Neurosci. 2019 Jun 28;11:170. doi: 10.3389/fnagi.2019.00170. eCollection 2019.

    PMID: 31316375BACKGROUND

  • Dalile, B., Verbeke, K., Van Oudenhove, L. and Vervliet, B. Nourishing the gut microbiota: The potential of prebiotics in microbiota-gut-brain axis research. Behavioral and Brain Sciences, (2019). 42.

    BACKGROUND

  • Quigley EM. Prebiotics and probiotics; modifying and mining the microbiota. Pharmacol Res. 2010 Mar;61(3):213-8. doi: 10.1016/j.phrs.2010.01.004. Epub 2010 Jan 18.

    PMID: 20080184BACKGROUND

  • Olveira G, Gonzalez-Molero I. An update on probiotics, prebiotics and symbiotics in clinical nutrition. Endocrinol Nutr. 2016 Nov;63(9):482-494. doi: 10.1016/j.endonu.2016.07.006. Epub 2016 Sep 12. English, Spanish.

    PMID: 27633133BACKGROUND

  • Bautista Justo, M.; García Oropeza, L.; Salcedo Hernández, R.; Parra Negrete, L. A. Azúcares en agaves (agave tequilana Weber) cultivados en el estado de guanajuato Acta Universitaria, vol. 11, núm. 1, abril, 2001, pp. 33-38

    BACKGROUND

  • Louzada ER, Ribeiro SML. Synbiotic supplementation, systemic inflammation, and symptoms of brain disorders in elders: A secondary study from a randomized clinical trial. Nutr Neurosci. 2020 Feb;23(2):93-100. doi: 10.1080/1028415X.2018.1477349. Epub 2018 May 23.

    PMID: 29788823BACKGROUND

  • Ginsberg TB, Powell L, Emrani S, Wasserman V, Higgins S, Chopra A, Cavalieri TA, Libon DJ. Instrumental Activities of Daily Living, Neuropsychiatric Symptoms, and Neuropsychological Impairment in Mild Cognitive Impairment. J Am Osteopath Assoc. 2019 Feb 1;119(2):96-101. doi: 10.7556/jaoa.2019.015.

    PMID: 30688355BACKGROUND

  • Pita Fernández, S., Pértega Díaz, S., Unidad de Epidemiología Clínica y Bioestadística. Complexo Hospitalario Universitario de A Coruña (España) CAD ATEN PRIMARIA 2001; 8: 191-195

    BACKGROUND

  • Hanchi H, Mottawea W, Sebei K, Hammami R. The Genus Enterococcus: Between Probiotic Potential and Safety Concerns-An Update. Front Microbiol. 2018 Aug 3;9:1791. doi: 10.3389/fmicb.2018.01791. eCollection 2018.

    PMID: 30123208BACKGROUND

  • Aguirre Leuke, Probióticos, prebióticos y simbióticos. El farmacéitico. 2017;542 pp. 25- 24

    BACKGROUND

  • Shi Y, Zhai M, Li J, Li B. Evaluation of safety and probiotic properties of a strain of Enterococcus faecium isolated from chicken bile. J Food Sci Technol. 2020 Feb;57(2):578-587. doi: 10.1007/s13197-019-04089-7. Epub 2019 Sep 11.

    PMID: 32116367BACKGROUND

  • Rogers GB, Keating DJ, Young RL, Wong ML, Licinio J, Wesselingh S. From gut dysbiosis to altered brain function and mental illness: mechanisms and pathways. Mol Psychiatry. 2016 Jun;21(6):738-48. doi: 10.1038/mp.2016.50. Epub 2016 Apr 19.

    PMID: 27090305BACKGROUND

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

JOSE JUAN ANTONIO IBARRA ARIAS, MEDICO CIRUJANO

CONTACT

5554197603jose.ibarra@anahuac.mx

ADELA ESCANDON CESARMAN, MEDICO CIRUJANO

CONTACT

5520459938adela.escandon.cesarman@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Responsable

Study Record Dates

First Submitted

August 19, 2022

First Posted

January 18, 2023

Study Start

November 16, 2022

Primary Completion

May 20, 2024

Study Completion

October 20, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Locations

ME(1)