Prospective Tolerability Assessment of a Probiotic Dietary Supplement

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: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Dietary supplement: Probiotic Dietary Supplement

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: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Frequency of participants who withdraw from the study due to adverse events during the supplementation period	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

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

Collaborators and Investigators

• Sponsor: Metagenics, Inc.
• Collaborators: National University of Natural Medicine

Publications and helpful links

General Publications

• Ryan JJ, Patno NM. Short-Term Tolerability, Safety, and Gut Microbial Composition Responses to a Multi-Strain Probiotic Supplement: An Open-Label Study in Healthy Adults. Integr Med (Encinitas). 2021 Feb;20(1):24-34.

Helpful Links

• Full Text

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 12, 2019
• Primary Completion (ACTUAL): August 23, 2019
• Study Completion (ACTUAL): August 23, 2019

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (ACTUAL): August 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID 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