Prospective Tolerability Assessment of a Probiotic Dietary Supplement
NCT ID: NCT04044144
Last Updated: 2022-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2019-08-12
2019-08-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Probiotic Dietary Supplement
Subjects will be asked to take 1 capsule per day of the dietary supplement for a period of 10 days
Probiotic Dietary Supplement
Dietary supplement containing a combination of 8 probiotic strains
Interventions
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Probiotic Dietary Supplement
Dietary supplement containing a combination of 8 probiotic strains
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
21 Years
75 Years
ALL
Yes
Sponsors
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National University of Natural Medicine
OTHER
Metagenics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Noelle Patno, PhD
Role: PRINCIPAL_INVESTIGATOR
Metagenics, Inc.
Locations
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Personalized Lifestyle Medicine Center
Gig Harbor, Washington, United States
Countries
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References
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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.
Related Links
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Other Identifiers
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2019-015
Identifier Type: -
Identifier Source: org_study_id
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