Status:
COMPLETED
A Study of the Next-generation Probiotic, Veillonella Atypica FB0054 vs Placebo
Lead Sponsor:
FitBiomics, Inc.
Collaborating Sponsors:
People Science, Inc.
Conditions:
Fatigue
Eligibility:
All Genders
18-65 years
Brief Summary
In this study, the investigators are assessing the ability of Veillonella (Veillonella atypica FB0054) to decrease fatigue and increase energy in a heterogeneous cohort of healthy adults compared to p...
Detailed Description
Veillonella is a novel probiotic that can metabolize lactic acid into propionate, which is an energy source for the body. In previous research, the investigators have shown that Veillonella can improv...
Eligibility Criteria
Inclusion
- Male or female adults aged 18 - 65 years.
- Willing and able to provide written informed consent.
- Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects.
- Agreement to comply with the protocol and study restrictions.
- Fluent in written and spoken English.
- In good general health as judged by the Investigator based on medical history.
- Willing to maintain daily exercise and diet habits throughout the 8 week study without making major lifestyle changes.
- Ability to use a personal smartphone device and download the Chloe app by People Science
Exclusion
- Currently pregnant, planning to become pregnant, or lactating during the next 12 weeks
- Have a significant acute or chronic coexisting illness, disorder, or condition that contraindicates, in the Principal Investigator's judgment, entry to the study.
- Currently taking immunosuppressive medications.
- Is considered immunosuppressed for any reason.
- Currently taking medications that could impair the integrity of the gut epithelia
- Has symptoms or an illness, disorder, or cognition that impairs the integrity of the gut epithelia.
- Current antibiotic use or planned oral antibiotic use over the course of the study.
- Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 7 2023
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT06141343
Start Date
August 1 2023
End Date
November 7 2023
Last Update
November 21 2023
Active Locations (1)
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1
FitBiomics, Inc.
New York, New York, United States, 10014