An interventional study of Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) Intervention Type: in Cognitive Impairment, sponsored by Anahuac University. Recruiting at 1 site in Mexico. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Anahuac University · Not applicable, Interventional, and Treatment
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.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 20 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Anahuac University is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Dietary Supplement: 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.
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.
Time frame: 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.
Time frame: : 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.
Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.
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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.
Start is estimated for Dec 2026; primary completion for Nov 2027, 10 months later.
Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 10 months is below that.
Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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