The Effect of Probiotic Supplementation on Cognitive and Emotional Functions in Healthy Elderly Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-17

Study Completion Date

2022-04-30

Brief Summary

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This study evaluates the cognitive and emotional effects of probiotics in healthy elderly patients.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Probiotic group

Participants will be treated with a daily capsule of a multi-species probiotic (3.3 billion Lactobacillus rhamnosus and Bifidobacterium lactis) during 10 weeks.

Group Type EXPERIMENTAL

Lactobacillus rhamnosus and Bifidobacterium lactis

Intervention Type DIETARY_SUPPLEMENT

Probiotics

Placebo group

Participants will receive a harmless substance (potato starch) during 10 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Lactobacillus rhamnosus and Bifidobacterium lactis

Probiotics

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* be aged 55 years or over,
* voluntarily agree to participate in the study in accordance with the Helsinki declaration,
* not be participating in another study that could interfere with the results.

Exclusion Criteria

* suffer from any serious mental illness other than depression and anxiety,
* score below 10 on the Mini-Mental State Examination (MMSE) (severe cognitive impairment)
* be using medications that affect cognition,
* taking anti-inflammatory drugs, antipsychotics, antibiotics and/or anxiolytics,
* have a serious illness (e.g. cancer, Parkinson's or Alzheimer's).

Minimum Eligible Age

56 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes