Prospective Tolerability Assessment of a Probiotic Dietary Supplement

April 4, 2022 updated by: Metagenics, Inc.
The dietary supplement being investigated is a formula containing a combination of eight probiotic strains. The combination formula was developed to support general gastrointestinal and immune health. Each of the strains in the formula have previously been studied in human subjects, including several clinical populations. However, the present eight strain combination formula has not previously been evaluated in human subjects. This prospective study will evaluate the tolerability of the eight strain formula in healthy adults.

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.

Detailed Description

Background & Significance:

The dietary supplement being investigated is a formula containing a combination of eight probiotic strains. The combination formula was developed to support general gastrointestinal and immune health. Each of the strains in the formula have previously been studied in human subjects, including several clinical populations. However, the present eight strain combination formula has not previously been evaluated in human subjects.

Research Design & Methods:

This prospective study will evaluate the tolerability of the eight strain formula in healthy adults over a 10-day period. The primary aim of the study is to assess tolerability as determined by the frequency of study participants who withdraw from the study due to adverse events.

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.
10

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
    • Washington
      • Gig Harbor, Washington, United States, 98332
        • Personalized Lifestyle Medicine Center

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

21 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Age 21-75 years

Exclusion Criteria:

  • Currently taking a probiotic, prebiotic, or fiber supplement (or they were taken within 10 days prior to screening)
  • Currently taking antibiotic, antiparasitic, or antifungal medications orally or intravenously (or they were taken within 28 days prior to screening)
  • Currently taking any supplements or medications impacting gastrointestinal motility
  • Active gastrointestinal infection
  • Current or previous history of chronic bowel disease
  • Current or previous history of liver disease
  • Current or previous history of chronic kidney disease
  • History of gastrointestinal surgery
  • A major medical or surgical event requiring hospitalization within 3 months prior to screening
  • Current or previous history of cardiovascular disease
  • Current or previous history of pre-Diabetes, diabetes mellitus, or hypoglycemia
  • Known infection with human immunodeficiency virus, tuberculosis, hepatitis B or hepatitis C
  • Genitourinary bacterial infections within 28 days prior to screening
  • Current or previous history of seizure disorder
  • Current or previous history of psychiatric illness
  • History of alcoholism
  • Cancer within the last 5 years
  • Smoking or use of nicotine containing products within 28 days prior to screening
  • Use of drugs of abuse and recreational drugs/substances within 12 months prior to screening
  • Known intolerance or allergy to ingredients in the study supplement
  • Women who are lactating, pregnant or planning pregnancy within the next two months
  • Currently participating in another interventional research study or participated in another interventional study within 28 days prior to screening

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: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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 Dietary Supplement
Subjects will be asked to take 1 capsule per day of the dietary supplement for a period of 10 days
Dietary supplement: Probiotic Dietary Supplement
Dietary supplement containing a combination of 8 probiotic strains

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
Frequency of participants who withdraw from the study due to adverse events during the supplementation period
Time Frame: 0-10 days
Tolerability of oral intake of the probiotic supplement will primarily be evaluated by determining the frequency of participants who withdraw from the study due to adverse events during the supplementation period
0-10 days

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
White blood cell count
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Red blood cell count
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Hemoglobin
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Hematocrit
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Mean corpuscular volume
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Mean corpuscular hemoglobin
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Mean corpuscular hemoglobin conc.
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Red cell distribution width
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Platelet count
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Mean platelet volume
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Absolute Neutrophils
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Absolute Lymphocytes
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Absolute Monocytes
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Absolute Eosinophils
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Absolute Basophils
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Neutrophils
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Lymphocytes
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Monocytes
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Eosinophils
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Basophils
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Albumin
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Globulin
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Albumin/Globulin Ratio
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Alkaline Phosphatase
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Alanine Transaminase
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Aspartate Aminotransferase
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Blood urea nitrogen (BUN)
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Creatinine
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
BUN/Creatinine ratio
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Calcium
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Carbon Dioxide
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Chloride
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Estimated Glomerular Filtration Rate
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Potassium
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Sodium
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Bilirubin
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days
Total Protein
Time Frame: 0-10 days
Frequency of adverse change before and after the supplementation period
0-10 days

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.
Metagenics, Inc.

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.
National University of Natural Medicine

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

Helpful Links

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.
August 12, 2019

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.
August 23, 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.
August 23, 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).
August 1, 2019

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.
August 1, 2019

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.
August 5, 2019

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.
April 6, 2022

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.
April 4, 2022

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.
April 1, 2022

More Information

Terms related to this study

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.
  • 2019-015

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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