Prospective Tolerability Assessment of a Probiotic Dietary Supplement

Not Applicable

Completed

• Conditions: Healthy Adults

• Registration Number: NCT04044144
• Lead Sponsor: Metagenics, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-05
• Study Start: 2019-08-12
• Primary Completion: 2019-08-23
• Study Completion: 2019-08-23
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of participants who withdraw from the study due to adverse events during the supplementation period	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Personalized Lifestyle Medicine Center; 🇺🇸 Gig Harbor, Washington, United States