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This study evaluates the cognitive and emotional effects of probiotics in healthy elderly patients.
Gut microbiota (GM) has focused as an important target for emotional and cognitive diseases, moreover in a population that show an altered GM such as elderly population as age-related changes. Several studies have shown that ageing alter GM, both in diversity and integrity.
Probiotics have demonstrated that correct or prevent age-related dysbiosis, in order to reduce or prevent intestinal permeability and associated inflammation, inhibit the generation of harmful and/or toxic metabolites, as well as promote the production of beneficial bacterial components.
The aim of this study is to assess the effectiveness of a multiprobiotic formulation as a therapeutic strategy to attenuate the emotional and cognitive decline associated with ageing in healthy adults over 55 years of age. The hypothesis is that administration of a multi-species probiotic for 10 weeks will slow and/or ameliorate the decline in emotional and cognitive function inherent to senescence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Experimental | Participants will be treated with a daily capsule of a multi-species probiotic (3.3 billion Lactobacillus rhamnosus and Bifidobacterium lactis) during 10 weeks. |
|
| Placebo group | Placebo Comparator | Participants will receive a harmless substance (potato starch) during 10 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus rhamnosus and Bifidobacterium lactis | Dietary Supplement | Probiotics |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Anxiety at 10 weeks | The State-Trait Anxiety Inventory. Score range: 20-80 | Before and after treatment (10 weeks) |
| Change from Baseline Depression at 10 weeks | The Beck Depression Inventory. Score range: 0-63. | Before and after treatment (10 weeks) |
| Change from Baseline General Cognitive Status at 10 weeks | Mini-Mental State Examination. Score range: 0-35 | Before and after treatment (10 weeks) |
| Change from Baseline Working Memory at 10 weeks | Digits task, Corsi task | Before and after treatment (10 weeks) |
| Change from Baseline Planning Ability at 10 weeks | Tower of London test | Before and after treatment (10 weeks) |
| Change from Baseline Problem-solving ability at 10 weeks | Wisconsin Card Sorting test | Before and after treatment (10 weeks) |
| Change from Baseline Selective attention, cognitive flexibility and response inhibition at 10 weeks | Stroop task | Before and after treatment (10 weeks) |
| Change from Baseline Visual Attention at 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Food Habits at 10 weeks | "24-hour recall" questionnaire | Before and after treatment (10 weeks) |
| Change from Baseline Alcohol Use at 10 weeks | The Alcohol Use Disorders Identification Test. Score range: 0-40 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PABLO R LOPEZ | Universidad de Almeria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Almeria | Almería | Almeria | 04120 | Spain | ||
| Universidad de Almeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38935259 | Derived | Ruiz-Gonzalez C, Cardona D, Rueda-Ruzafa L, Rodriguez-Arrastia M, Ropero-Padilla C, Roman P. Cognitive and Emotional Effect of a Multi-species Probiotic Containing Lactobacillus rhamnosus and Bifidobacterium lactis in Healthy Older Adults: A Double-Blind Randomized Placebo-Controlled Crossover Trial. Probiotics Antimicrob Proteins. 2025 Oct;17(5):3525-3537. doi: 10.1007/s12602-024-10315-2. Epub 2024 Jun 27. |
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| Placebo |
| Dietary Supplement |
Placebo |
|
Trail Making Test
| Before and after treatment (10 weeks) |
| Change from Baseline Motor impulsivity or inhibitory response at 10 weeks | Go/No-Go task | Before and after treatment (10 weeks) |
| Change from Baseline Choice impulsivity or impulsive decision-making at 10 weeks | Iowa Gambling Task | Before and after treatment (10 weeks) |
| Before and after treatment (10 weeks) |
| Change from Baseline Body Composition at 10 weeks | Fat mass. Body fat mass. Fat-free mass. Total body water. | Before and after treatment (10 weeks) |
| Change from Baseline Physical Activity at 10 weeks | International Physical Activity Questionnaire | Before and after treatment (10 weeks) |
| Change from Baseline Stool Consistency at 10 weeks | The Bristol Scale | Before and after treatment (10 weeks) |
| Change from Baseline Sleep Quality at 10 weeks | The Pittsburgh Sleep Quality Index Questionnaire. Score range: 0-21 | Before and after treatment (10 weeks) |
| Change from Baseline Perceived Stress at 10 weeks | Perceived Stress Questionnaire. Score range: 0-1 | Before and after treatment (10 weeks) |
| Change from Baseline Gastrointestinal Symptom at 10 weeks | Gastrointestinal Symptom Rating Scale | Before and after treatment (10 weeks) |
| La Cañada de San Urbano |
| Almeria |
| 04120 |
| Spain |
| Pablo Roman | Almería | 04120 | Spain |