Probiotic on Psychological and Cognitive Effects

February 19, 2020 updated by: John Gunstad, Kent State University

Evaluation of a Probiotic on Psychological and Cognitive Effects in Middle and Older Adults

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Kent, Ohio, United States, 44242
        • Kent State Uniersity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Probiotic
Participants in this arm will receive probiotic supplementation for 12 weeks (Lactobacillus Rhamnosus GG)
Dietary supplement: Probiotic - Lactobacillus Rhamnosus GG
2 capsules per day for 90 days
PLACEBO_COMPARATOR: Control
Participants in this arm will receive placebo that look similar to probiotics
Other: Placebo
2 placebo capsules per day for 90 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in score on Center for Epidemiologic Studies Depression - R (CES-D-R)
Time Frame: Baseline and 12 week follow up
Depressive symptoms
Baseline and 12 week follow up
Change in score on State-Trait Anxiety Inventory
Time Frame: Baseline and 12 week follow up
Anxiety symptoms
Baseline and 12 week follow up
Change in score on Perceived Stress Scale
Time Frame: Baseline and 12 week follow up
Subjective stress
Baseline and 12 week follow up
Change in score on Positive and Negative Affect Schedule
Time Frame: Baseline and 12 week follow up
Fluctuations in affect
Baseline and 12 week follow up
Change in score on Profile of Mood States
Time Frame: Baseline and 12 week follow up
Fluctuations in affect - acute
Baseline and 12 week follow up
Change in score on Warwick-Edinburgh Mental Well-Being Scale
Time Frame: Baseline and 12 week follow up
Subjective wellbeing
Baseline and 12 week follow up
Change in score on OECD Life Satisfaction scale (short)
Time Frame: Baseline and 12 week follow up
Subjective wellbeing - general
Baseline and 12 week follow up
Change in score on Response to Stressful Events Scale
Time Frame: Baseline and 12 week follow up
Emotion regulation
Baseline and 12 week follow up
Change in score on Connor-Davidson Resilience Scale
Time Frame: Baseline and 12 week follow up
Emotional resilience
Baseline and 12 week follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Picture Sequence Memory Test and Auditory Verbal Learning Test scores
Time Frame: Baseline and 12 week follow up
Memory
Baseline and 12 week follow up
Change in Dimension Card Sort Test, Flanker Inhibitory Control, and List Sorting Working Memory Test scores
Time Frame: Baseline and 12 week follow up
Executive function/Attention
Baseline and 12 week follow up
Change in Pattern Comparison Processing Speed Test scores
Time Frame: Baseline and 12 week follow up
Processing Speed
Baseline and 12 week follow up
Change in SF-36 scores
Time Frame: Baseline and 12 week follow up
Quality of Life
Baseline and 12 week follow up
Change in Pittsburgh Sleep Quality Index scores
Time Frame: Baseline and 12 week follow up
Sleep patterns
Baseline and 12 week follow up
Change in Gastrointestinal Symptom Rating Scale scores
Time Frame: Baseline and 12 week follow up
Subjective gastrointestinal symptoms
Baseline and 12 week follow up
Change in HbA1c and fasting glucose values
Time Frame: Baseline and 12 week follow up
Laboratory measures of glycemic control
Baseline and 12 week follow up
Change in C-reactive protein, Interleukin-6, and TNF-alpha values
Time Frame: Baseline and 12 week follow up
Laboratory measures of inflammation
Baseline and 12 week follow up
Change in Total Cholesterol, HDL, LDL, and VLDL values
Time Frame: Baseline and 12 week follow up
Laboratory meausres of lipid levels
Baseline and 12 week follow up
Change in waking cortisol levels
Time Frame: Baseline and 12 week follow up
Laboratory measure of cortisol
Baseline and 12 week follow up
Change in composition of the gut microbiome
Time Frame: Baseline and 12 week follow up
Laboratory measure of gut microbiome
Baseline and 12 week follow up
Change in oral microbiome composition
Time Frame: Baseline and 12 week follow up
Laboratory measure of oral microbiome
Baseline and 12 week follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kent State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
iHealth

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Gunstad, Ph.D., Kent State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Kent State University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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