Prospective Tolerability Assessment of a Probiotic Dietary Supplement

Healthy Adults Clinical Trial

Official title:

Prospective Tolerability Assessment of a Probiotic Dietary Supplement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04044144
• Other study ID #: 2019-015
• Status: Completed
• Phase: N/A
• Start date: August 12, 2019
• Est. completion date: August 23, 2019

Study information

• Verified date: April 2022
• Source: Metagenics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 23, 2019
• Est. primary completion date: August 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Dietary Supplement:
• Probiotic Dietary Supplement
Dietary supplement containing a combination of 8 probiotic strains

Locations

Country	Name	City	State
United States	Personalized Lifestyle Medicine Center	Gig Harbor	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Metagenics, Inc.	National University of Natural Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

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

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