NCT04044144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

August 12, 2019

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2019

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

11 days

First QC Date

August 1, 2019

Last Update Submit

April 4, 2022

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (37)

  • White blood cell count

    0-10 days

  • Red blood cell count

    0-10 days

  • Hemoglobin

    0-10 days

  • Hematocrit

    0-10 days

  • Mean corpuscular volume

    0-10 days

  • +32 more secondary outcomes

Study Arms (1)

Probiotic Dietary Supplement

EXPERIMENTAL

Subjects will be asked to take 1 capsule per day of the dietary supplement for a period of 10 days

Dietary Supplement: Probiotic Dietary Supplement

Interventions

Probiotic Dietary SupplementDIETARY_SUPPLEMENT

Dietary supplement containing a combination of 8 probiotic strains

Probiotic Dietary Supplement

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Age 21-75 years

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Personalized Lifestyle Medicine Center

Gig Harbor, Washington, 98332, United States

Location

Related 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.

    PMID: 34393673RESULT

Related Links

Study Officials

  • Noelle Patno, PhD

    Metagenics, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2019

First Posted

August 5, 2019

Study Start

August 12, 2019

Primary Completion

August 23, 2019

Study Completion

August 23, 2019

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)