Status:
COMPLETED
Prospective Tolerability Assessment of a Probiotic Dietary Supplement
Lead Sponsor:
Metagenics, Inc.
Collaborating Sponsors:
National University of Natural Medicine
Conditions:
Healthy Adults
Eligibility:
All Genders
21-75 years
Phase:
NA
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....
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 gastro...
Eligibility Criteria
Inclusion
- \- Age 21-75 years
Exclusion
- 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
Key Trial Info
Start Date :
August 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04044144
Start Date
August 12 2019
End Date
August 23 2019
Last Update
April 6 2022
Active Locations (1)
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1
Personalized Lifestyle Medicine Center
Gig Harbor, Washington, United States, 98332