Clinical trial NCT04044144: Prospective Tolerability Assessment of a Probiotic Dietary Supplement
Official title: Prospective Tolerability Assessment of a Probiotic Dietary Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Lead sponsor: Metagenics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National University of Natural Medicine
First posted: 2019-08-05
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of participants who withdraw from the study due to adverse events during the supplementation period
timeFrame: 0-10 days
Secondary outcomes:
measure: White blood cell count
timeFrame: 0-10 days
measure: Red blood cell count
timeFrame: 0-10 days
measure: Hemoglobin
timeFrame: 0-10 days
measure: Hematocrit
timeFrame: 0-10 days
measure: Mean corpuscular volume
timeFrame: 0-10 days
measure: Mean corpuscular hemoglobin
timeFrame: 0-10 days
measure: Mean corpuscular hemoglobin conc.
timeFrame: 0-10 days
measure: Red cell distribution width
timeFrame: 0-10 days
measure: Platelet count
timeFrame: 0-10 days
measure: Mean platelet volume
timeFrame: 0-10 days
measure: Absolute Neutrophils
timeFrame: 0-10 days
measure: Absolute Lymphocytes
timeFrame: 0-10 days
measure: Absolute Monocytes
timeFrame: 0-10 days
measure: Absolute Eosinophils
timeFrame: 0-10 days
measure: Absolute Basophils
timeFrame: 0-10 days
measure: Neutrophils
timeFrame: 0-10 days
measure: Lymphocytes
timeFrame: 0-10 days
measure: Monocytes
timeFrame: 0-10 days
measure: Eosinophils
timeFrame: 0-10 days
measure: Basophils
timeFrame: 0-10 days
measure: Albumin
timeFrame: 0-10 days
measure: Globulin
timeFrame: 0-10 days
measure: Albumin/Globulin Ratio
timeFrame: 0-10 days
measure: Alkaline Phosphatase
timeFrame: 0-10 days
measure: Alanine Transaminase
timeFrame: 0-10 days
measure: Aspartate Aminotransferase
timeFrame: 0-10 days
measure: Blood urea nitrogen (BUN)
timeFrame: 0-10 days
measure: Creatinine
timeFrame: 0-10 days
measure: BUN/Creatinine ratio
timeFrame: 0-10 days
measure: Calcium
timeFrame: 0-10 days
measure: Carbon Dioxide
timeFrame: 0-10 days
measure: Chloride
timeFrame: 0-10 days
measure: Estimated Glomerular Filtration Rate
timeFrame: 0-10 days
measure: Potassium
timeFrame: 0-10 days
measure: Sodium
timeFrame: 0-10 days
measure: Bilirubin
timeFrame: 0-10 days
measure: Total Protein
timeFrame: 0-10 days
Other outcomes:
Locations:
city: Gig Harbor
country: United States
facility: Personalized Lifestyle Medicine Center
state: Washington
Study officials:
affiliation: Metagenics, Inc.
name: Noelle Patno, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.