Cognitive ImpairmentNCT05688618
Effect of the Administration of a Symbiotic (E. Faecium and Agave Inulin) on Mild Cognitive Impairment in Older Adults
A study testing Enteroccocus Facieum and Agave Inulin in people with Cognitive Impairment, run by Anahuac University at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 70 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Enteroccocus Facieum and Agave Inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteMexico
- Study dates
- 16 Nov 2022to 20 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients with mild cognitive impairment
- Patients who sign the informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital ABC Santa Fe
Mexico City, 05300
Adela Escandon-Cesarman, Medical degree, 5520459938, adela.escandon.cesarman@gmail.com
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.
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.
Read the 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.
- Conditions
- Cognitive Impairment
- Being tested
- Enteroccocus Facieum and Agave Inulin, Placebo
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboOther
A pack of unsweetened almond powder milk will be administered daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Not described Receives: Dietary Supplement: Enteroccocus Facieum and Agave Inulin |
| Control group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive impairment
Change in Score for Mini mental state examination
Measured: 8 weeks
Cognitive impairment
Change in Score for Rey-Osterrieth complex figure
Measured: 8 weeks
Cognitive impairment
Change in Score for AeRAC (Instrumento de expectativas de autoeficacia)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start16 Nov 2022
- Primary completion20 May 2024
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anahuac University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Juan Antonio Ibarra Arias, Anahuac University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688618
- Sponsor's protocol ID
- CEI-004-20160729
- Status last verified
- Jul 2024
- First submitted
- 19 Aug 2022
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27719970Benavides-Caro, C. Deterioro cognitivo en el adulto mayor. Medigraphic, (2017). 40(2).
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.
PubMed 30618722Landefeld, 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.
PubMed 24145578Grammas 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.
PubMed 21439035Ticinesi 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.
PubMed 30214170Novotny 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.
PubMed 31316375Dalile, 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.
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.
PubMed 20080184Olveira 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.
PubMed 27633133Bautista 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
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.
PubMed 29788823Ginsberg 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.
PubMed 30688355Pita 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Administration of a Symbiotic (E. Faecium and Agave Inulin) on Mild Cognitive Impairment in Older Adults
- ClinicalTrials.gov ID
- NCT05688618
- Acronym / sponsor ID
- CEI-004-20160729
- Conditions
- Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Anahuac UniversityUniversity, hospital or other
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Dietary Supplement: Enteroccocus Facieum and Agave Inulin |
| Control group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients with mild cognitive impairment
- Patients who sign the informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteroccocus Facieum and Agave InulinA pack of symbiotic powder with 1 gram of e. facieum and 8g of agave inulin will be administered daily for 8 weeks | Dietary supplement | Experimental group |
| PlaceboA pack of unsweetened almond powder milk will be administered daily for 8 weeks | Other | Control group |
Primary outcome
Cognitive impairment
Time frame: 8 weeks
Change in Score for Mini mental state examination
Cognitive impairment
Time frame: 8 weeks
Change in Score for Rey-Osterrieth complex figure
Cognitive impairment
Time frame: 8 weeks
Change in Score for AeRAC (Instrumento de expectativas de autoeficacia)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 27719970Borras 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.
- BackgroundBenavides-Caro, C. Deterioro cognitivo en el adulto mayor. Medigraphic, (2017). 40(2).
- Background: PubMed 30618722Romo-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.
- BackgroundLandefeld, C. Current geriatric diagnosis & treatment. New York: McGraw-Hill Professional. (2004).
- Background: PubMed 24145578Lin 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.
- Background: PubMed 21439035Grammas 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.
- Background: PubMed 30214170Ticinesi 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.
- Background: PubMed 31316375Novotny 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.
- BackgroundDalile, 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: PubMed 20080184Quigley 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.
- Background: PubMed 27633133Olveira 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.
- BackgroundBautista 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
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteroccocus Facieum and Agave Inulin in people with Cognitive Impairment, run by Anahuac University at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JOSE JUAN ANTONIO IBARRA ARIAS, MEDICO CIRUJANO (5554197603, jose.ibarra@anahuac.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive impairment (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05688618, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.