An interventional study of Lactobacillus rhamnosus and Bifidobacterium lactis and Placebo in Healthy, sponsored by Universidad de Almeria. Completed at 3 sites in Spain. Open to participants aged 56 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-01.
Sponsored by Universidad de Almeria · Not applicable, Interventional, and Prevention
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.
Universidad de Almeria is the lead sponsor of 71 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be treated with a daily capsule of a multi-species probiotic (3.3 billion Lactobacillus rhamnosus and Bifidobacterium lactis) during 10 weeks.
Dietary Supplement: Lactobacillus rhamnosus and Bifidobacterium lactis
Participants will receive a harmless substance (potato starch) during 10 weeks.
Dietary Supplement: Placebo
Probiotics
Placebo
Change from Baseline Anxiety at 10 weeks
The State-Trait Anxiety Inventory. Score range: 20-80
Time frame: Before and after treatment (10 weeks)
Change from Baseline Depression at 10 weeks
The Beck Depression Inventory. Score range: 0-63.
Time frame: Before and after treatment (10 weeks)
Change from Baseline General Cognitive Status at 10 weeks
Mini-Mental State Examination. Score range: 0-35
Time frame: Before and after treatment (10 weeks)
Change from Baseline Working Memory at 10 weeks
Digits task, Corsi task
Time frame: Before and after treatment (10 weeks)
Change from Baseline Planning Ability at 10 weeks
Tower of London test
Time frame: Before and after treatment (10 weeks)
Change from Baseline Problem-solving ability at 10 weeks
Wisconsin Card Sorting test
Time frame: Before and after treatment (10 weeks)
Change from Baseline Selective attention, cognitive flexibility and response inhibition at 10 weeks
Stroop task
Time frame: Before and after treatment (10 weeks)
Change from Baseline Visual Attention at 10 weeks
Trail Making Test
Time frame: Before and after treatment (10 weeks)
Change from Baseline Motor impulsivity or inhibitory response at 10 weeks
Go/No-Go task
Time frame: Before and after treatment (10 weeks)
Change from Baseline Choice impulsivity or impulsive decision-making at 10 weeks
Iowa Gambling Task
Time frame: Before and after treatment (10 weeks)
Change from Baseline Food Habits at 10 weeks
"24-hour recall" questionnaire
Time frame: Before and after treatment (10 weeks)
Change from Baseline Alcohol Use at 10 weeks
The Alcohol Use Disorders Identification Test. Score range: 0-40
Time frame: 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.
Time frame: Before and after treatment (10 weeks)
Change from Baseline Physical Activity at 10 weeks
International Physical Activity Questionnaire
Time frame: Before and after treatment (10 weeks)
Change from Baseline Stool Consistency at 10 weeks
The Bristol Scale
Time frame: Before and after treatment (10 weeks)
Change from Baseline Sleep Quality at 10 weeks
The Pittsburgh Sleep Quality Index Questionnaire. Score range: 0-21
Time frame: Before and after treatment (10 weeks)
Change from Baseline Perceived Stress at 10 weeks
Perceived Stress Questionnaire. Score range: 0-1
Time frame: Before and after treatment (10 weeks)
Change from Baseline Gastrointestinal Symptom at 10 weeks
Gastrointestinal Symptom Rating Scale
Time frame: Before and after treatment (10 weeks)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Universidad de Almeria