Cognitive ImpairmentNCT07818369
Synbiotic LA-5 and Agave Inulin for Mild Cognitive Impairment
A study testing Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) Intervention Type: in people with Cognitive Impairment, run by Anahuac University at 1 site in Mexico.
Trial summary
This pilot randomized, double-blind, crossover clinical trial will evaluate the effect of a synbiotic containing Lactobacillus acidophilus LA-5 and agave inulin on mild cognitive impairment (MCI) in adults aged 60-75 years attending the Defense Medical Specialties Unit. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) Intervention Type:
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 31 Dec 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 60 to 75 years.
- Presence of mild cognitive impairment (MCI) determined by neuropsychological testing, meeting at least two of the following three established cutoff criteria:
- Montreal Cognitive Assessment (MoCA): 19-26 points.
- Memory Alteration Test (M@T): 28-37 points.
- Mini-Mental State Examination (MMSE): 12-24 points.
- Ability and willingness to provide written informed consent; consent may be provided by a family member or legal representative when necessary.
Who cannot join
- Previous diagnosis of severe cognitive impairment, Alzheimer disease, vascular dementia, or another neurodegenerative disorder affecting cognition.
- History of cerebral ischemia, cerebrovascular events, traumatic brain injury, or advanced-stage renal disease.
- Diagnosis of type 2 diabetes mellitus.
- Diagnosed dysbiosis or inflammatory bowel disease, including ulcerative colitis or Crohn disease.
- Use of antibiotics, laxatives, probiotics, or prebiotics within the 3 months prior to enrollment.
- Habitual consumption of fermented foods or fiber-rich supplements, particularly fiber intake >18 g/day.
Show all 12Show fewer
- Excessive alcohol consumption, defined as ≥2 alcoholic drinks per day, or history of alcohol dependence.
- Chronic use of medications that may interfere with the microbiota-gut-brain axis, including immunosuppressants, antipsychotics, or corticosteroids.
- Recent surgery within the previous 3 months or a planned medical intervention during the study period.
- Known adverse reaction or hypersensitivity to any component of the synbiotic or to almond powder.
- Uncontrolled chronic stress identified by clinical assessment.
- Participation in intense physical activity or high-performance sports during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Unidad de Especialidades Médicas de la Defensa (UEMD)
Mexico City, Mexico City, 11200
Antonio Ibarra, PhD, 55 54197603, jose.ibarra@anahuac.mx
About this study
Official title: Effect of a Symbiotic (Lactobacillus Acidophilus LA-5 and Agave Inulin) on Mild Cognitive Impairment in Older Adults of the Defense Medical Specialties Unit
This pilot randomized, double-blind, crossover clinical trial will evaluate the effect of a synbiotic containing Lactobacillus acidophilus LA-5 and agave inulin on mild cognitive impairment (MCI) in adults aged 60-75 years attending the Defense Medical Specialties Unit. Forty participants with MCI will be randomized into two groups of 20 participants. The intervention will consist of daily administration of L. acidophilus LA-5 (4 × 10⁹ CFU), 7 g of agave inulin, and almond powder for 12 weeks, while the control group will receive almond powder as the vehicle. After a two-week washout period, participants will cross over to the alternate intervention for an additional 12 weeks.
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), Memory Alteration Test (M@T), and Mini-Mental State Examination (MMSE). Secondary assessments will explore potential mechanisms of the microbiota-gut-brain axis by measuring fecal L. acidophilus LA-5 and butyrate, as well as serum BDNF and inflammatory biomarkers including IL-1β, IL-6, IL-10, and TNF-α.
The study aims to determine whether synbiotic supplementation improves cognitive performance in older adults with MCI and whether these changes are accompanied by modifications in gut microbial activity, short-chain fatty acid production, neurotrophic signaling, and systemic inflammation.
- Conditions
- Cognitive Impairment
- Being tested
- Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) Intervention Type:
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) Intervention Type:Dietary supplement
Participants will receive 2 g of Lactobacillus acidophilus LA-5 (4 × 10⁹ CFU), 7 g of agave inulin, and 20 g of almond powder dissolved in water, administered orally once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic and Control | Experimental | Participants will receive the synbiotic intervention once daily for 12 weeks. The synbiotic consists of 2 g of Lactobacillus acidophilus LA-5 (4 × 10⁹ CFU), 7 g of agave inulin, and 20 g of almond powder dissolved in water. After the first 12-week intervention period, participants will undergo a 2-week washout period and will then cross over to the control intervention, consisting of 29 g of almond powder dissolved in water once daily for 12 weeks. Receives: Dietary Supplement: Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) Intervention Type: |
| Control and Synbiotic | Experimental | Participants will receive the control intervention, consisting of 29 g of almond powder dissolved in water once daily for 12 weeks. After a 2-week washout period, participants will cross over to the synbiotic intervention and receive 2 g of Lactobacillus acidophilus LA-5 (4 × 10⁹ CFU), 7 g of agave inulin, and 20 g of almond powder dissolved in water once daily for 12 weeks. Receives: Dietary Supplement: Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) Intervention Type: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montreal Cognitive Assessment (MoCA) Score
The Montreal Cognitive Assessment (MoCA) will be used to assess changes in global cognitive function. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance. A clinically meaningful improvement will be defined as an increase of at least 2 points from baseline, according to the study protocol.
Measured: Baseline, end of the first intervention phase, and end of the second intervention phase.
Change in Memory Alteration Test (M@T) Score
he Memory Alteration Test (M@T) will be used to assess changes in memory function. The total score ranges from 0 to 50 points, with higher scores indicating better memory performance. The test evaluates orientation and several memory domains, including semantic, free-recall, and cued-recall components. A clinically meaningful improvement will be defined as an increase of at least 2 points from baseline.
Measured: : Baseline, end of the first intervention phase, and end of the second intervention phase.
Change in Mini-Mental State Examination (MMSE) Score
The Mini-Mental State Examination (MMSE) will be used to assess changes in global cognitive function. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance. A clinically meaningful improvement will be defined as an increase of at least 1.5 points from baseline, according to the study protocol.
Measured: Baseline, end of the first intervention phase, and end of the second intervention phase.
Secondary outcomes (7)
Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Concentration
Serum brain-derived neurotrophic factor (BDNF) concentration will be quantified using enzyme-linked immunosorbent assay (ELISA). Results will be expressed in pg/mL. There is no predefined minimum or maximum score. Higher BDNF concentrations indicate greater circulating levels of this neurotrophic factor.
Measured: Baseline, end of the first intervention phase, and end of the second intervention phase.
Change in Interleukin-1 Beta (IL-1β) Concentration
IL-1β concentration will be quantified using ELISA and expressed in pg/mL. There is no predefined minimum or maximum score. Higher concentrations indicate greater levels of this pro-inflammatory cytokine.
Measured: Baseline, end of the first intervention phase, and end of the second intervention phase.
Change in Interleukin-6 (IL-6) Concentration
IL-6 concentration will be quantified using ELISA and expressed in pg/mL. There is no predefined minimum or maximum score. Higher concentrations indicate greater levels of this pro-inflammatory cytokine.
Measured: Baseline, end of the first intervention phase, and end of the second intervention phase.
Change in Tumor Necrosis Factor Alpha (TNF-α) Concentration
TNF-α concentration will be quantified using ELISA and expressed in pg/mL. There is no predefined minimum or maximum score. Higher concentrations indicate greater levels of this pro-inflammatory cytokine.
Measured: Baseline, end of the first intervention phase, and end of the second intervention phase.
Change in Interleukin-10 (IL-10) Concentration
IL-10 concentration will be quantified using ELISA and expressed in pg/mL. There is no predefined minimum or maximum score. Higher concentrations indicate greater levels of this anti-inflammatory cytokine.
Measured: Baseline, end of the first intervention phase, and end of the second intervention phase.
Change in Fecal Butyrate Concentration
Fecal butyrate concentration will be quantified using gas chromatography with flame ionization detection (GC-FID). Results will be expressed in mmol/g of fecal sample. There is no predefined minimum or maximum score. Higher concentrations indicate greater fecal butyrate production.
Measured: Baseline, end of the first intervention phase, and end of the second intervention phase.
Change in Fecal Lactobacillus acidophilus LA-5 Count
Fecal Lactobacillus acidophilus LA-5 will be quantified by colony-forming unit counts using selective MRS culture medium under anaerobic conditions. Results will be expressed as CFU/g of fecal sample. There is no predefined minimum or maximum score. Higher values indicate greater fecal abundance of L. acidophilus LA-5.
Measured: Baseline, end of the first intervention phase, and end of the second intervention phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start31 Dec 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 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
- NCT07818369
- Sponsor's protocol ID
- CEI202513
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Symbiotic (Lactobacillus Acidophilus LA-5 and Agave Inulin) on Mild Cognitive Impairment in Older Adults of the Defense Medical Specialties Unit
- ClinicalTrials.gov ID
- NCT07818369
- Acronym / sponsor ID
- CEI202513
- Conditions
- Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Anahuac UniversityUniversity, hospital or other
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 14 Sep 2026 (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.
This pilot randomized, double-blind, crossover clinical trial will evaluate the effect of a synbiotic containing Lactobacillus acidophilus LA-5 and agave inulin on mild cognitive impairment (MCI) in adults aged 60-75 years attending the Defense Medical Specialties Unit. Forty participants with MCI will be randomized into two groups of 20 participants. The intervention will consist of daily administration of L. acidophilus LA-5 (4 × 10⁹ CFU), 7 g of agave inulin, and almond powder for 12 weeks, while the control group will receive almond powder as the vehicle. After a two-week washout period, participants will cross over to the alternate intervention for an additional 12 weeks.
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), Memory Alteration Test (M@T), and Mini-Mental State Examination (MMSE). Secondary assessments will explore potential mechanisms of the microbiota-gut-brain axis by measuring fecal L. acidophilus LA-5 and butyrate, as well as serum BDNF and inflammatory biomarkers including IL-1β, IL-6, IL-10, and TNF-α.
The study aims to determine whether synbiotic supplementation improves cognitive performance in older adults with MCI and whether these changes are accompanied by modifications in gut microbial activity, short-chain fatty acid production, neurotrophic signaling, and systemic inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic and Control | Experimental | Dietary Supplement: Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) Intervention Type:Participants will receive the synbiotic intervention once daily for 12 weeks. The synbiotic consists of 2 g of Lactobacillus acidophilus LA-5 (4 × 10⁹ CFU), 7 g of agave inulin, and 20 g of almond powder dissolved in water. After the first 12-week intervention period, participants will undergo a 2-week washout period and will then cross over to the control intervention, consisting of 29 g of almond powder dissolved in water once daily for 12 weeks. |
| Control and Synbiotic | Experimental | Dietary Supplement: Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) Intervention Type:Participants will receive the control intervention, consisting of 29 g of almond powder dissolved in water once daily for 12 weeks. After a 2-week washout period, participants will cross over to the synbiotic intervention and receive 2 g of Lactobacillus acidophilus LA-5 (4 × 10⁹ CFU), 7 g of agave inulin, and 20 g of almond powder dissolved in water once daily for 12 weeks. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 60 to 75 years.
- Presence of mild cognitive impairment (MCI) determined by neuropsychological testing, meeting at least two of the following three established cutoff criteria:
- Montreal Cognitive Assessment (MoCA): 19-26 points.
- Memory Alteration Test (M@T): 28-37 points.
- Mini-Mental State Examination (MMSE): 12-24 points.
Key exclusion criteria (12 listed)
- Previous diagnosis of severe cognitive impairment, Alzheimer disease, vascular dementia, or another neurodegenerative disorder affecting cognition.
- History of cerebral ischemia, cerebrovascular events, traumatic brain injury, or advanced-stage renal disease.
- Diagnosis of type 2 diabetes mellitus.
- Diagnosed dysbiosis or inflammatory bowel disease, including ulcerative colitis or Crohn disease.
- Use of antibiotics, laxatives, probiotics, or prebiotics within the 3 months prior to enrollment.
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 |
|---|---|---|
| Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) Intervention Type:Participants will receive 2 g of Lactobacillus acidophilus LA-5 (4 × 10⁹ CFU), 7 g of agave inulin, and 20 g of almond powder dissolved in water, administered orally once daily for 12 weeks. | Dietary supplement | Control and Synbiotic, Synbiotic and Control |
Primary outcome
Change in Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.
The Montreal Cognitive Assessment (MoCA) will be used to assess changes in global cognitive function. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance. A clinically meaningful improvement will be defined as an increase of at least 2 points from baseline, according to the study protocol.
Change in Memory Alteration Test (M@T) Score
Time frame: : Baseline, end of the first intervention phase, and end of the second intervention phase.
he Memory Alteration Test (M@T) will be used to assess changes in memory function. The total score ranges from 0 to 50 points, with higher scores indicating better memory performance. The test evaluates orientation and several memory domains, including semantic, free-recall, and cued-recall components. A clinically meaningful improvement will be defined as an increase of at least 2 points from baseline.
Change in Mini-Mental State Examination (MMSE) Score
Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.
The Mini-Mental State Examination (MMSE) will be used to assess changes in global cognitive function. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance. A clinically meaningful improvement will be defined as an increase of at least 1.5 points from baseline, according to the study protocol.
7 secondary outcomes
Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Concentration
Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.
Change in Interleukin-1 Beta (IL-1β) Concentration
Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.
Change in Interleukin-6 (IL-6) Concentration
Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.
Change in Tumor Necrosis Factor Alpha (TNF-α) Concentration
Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.
Change in Interleukin-10 (IL-10) Concentration
Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.
Change in Fecal Butyrate Concentration
Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.
Change in Fecal Lactobacillus acidophilus LA-5 Count
Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) Intervention Type: 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Ibarra, PhD (52 55 54197603, jose.ibarra@anahuac.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montreal Cognitive Assessment (MoCA) Score (time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.). 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?
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 14 Sep 2026.