Probiotic on Psychological and Cognitive Effects

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2019-07-01

Brief Summary

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This study will determine whether supplementation of probiotic Lactobacillus Rhamnosus GG improves psychological status in middle age and older adults through a 12-week, randomized, double-blind, placebo-controlled clinical trial. Secondary analyses will be conducted to examine the possible benefits of probiotic supplementation on cognitive function and markers of physical health.

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Detailed Description

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Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Probiotic

Participants in this arm will receive probiotic supplementation for 12 weeks (Lactobacillus Rhamnosus GG)

Group Type EXPERIMENTAL

Probiotic - Lactobacillus Rhamnosus GG

Intervention Type DIETARY_SUPPLEMENT

2 capsules per day for 90 days

Control

Participants in this arm will receive placebo that look similar to probiotics

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

2 placebo capsules per day for 90 days

Interventions

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Probiotic - Lactobacillus Rhamnosus GG

2 capsules per day for 90 days

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 placebo capsules per day for 90 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 55-75 years
* Able to speak and read English

Exclusion Criteria

* History of neurological, developmental, or severe psychiatric disorder (e.g. dementia, stroke, schizophrenia);
* Antibiotic use in the past 30 days;
* History of significant stomach or GI surgery (e.g. gastric bypass, cholecystectomy);
* History of alcohol or illicit drug dependence;
* History of severe heart, kidney, or liver problems (e.g. heart failure, liver failure);
* Regular use of an acid-blocking medication in the past 30 days (i.e. proton pump inhibitor, H2 blocker);
* Likely immunosuppression (e.g. chemotherapy treatment);
* Regular use of other pre- or probiotic supplements in the past 30 days;
* Severe gastrointestinal conditions including celiac disease, Crohn's disease, or diverticulitis.

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes