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

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688618
• Other study ID #: CEI-004-20160729
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: August 20, 2024

Study information

• Verified date: February 2024
• Source: Anahuac University
• Contact: JOSE JUAN ANTONIO IBARRA ARIAS, MEDICO CIRUJANO
• Phone: 5554197603
• Email: jose.ibarra[@]anahuac.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: August 20, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Dietary Supplement:
• Enteroccocus Facieum and Agave Inulin
A pack of symbiotic powder with 1 gram of e. facieum and 8g of agave inulin will be administered daily for 8 weeks

Other:
• Placebo
A pack of unsweetened almond powder milk will be administered daily for 8 weeks

Locations

Country	Name	City	State
Mexico	Hospital ABC Santa Fe	Ciudad de Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Anahuac University

Country where clinical trial is conducted

Mexico, 

References & Publications (19)

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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

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

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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

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. Erratum In: Ann Intern Med. 2014 Jan 7;160(1):72. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive impairment	Change in Score for Mini mental state examination	8 weeks
Primary	Cognitive impairment	Change in Score for Rey-Osterrieth complex figure	8 weeks
Primary	Cognitive impairment	Change in Score for AeRAC (Instrumento de expectativas de autoeficacia)	8 weeks

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