A Study of the Next-generation Probiotic, Veillonella Atypica FB0054 vs Placebo

Completed · Has a placebo group

Conditions studied: Fatigue

In brief

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 placebo. Study subjects will fill out a baseline health and habit survey followed by daily and weekly surveys over a two week baseline period to understand their baseline habits, fatigue, and energy levels. After this, subjects will take one daily capsule orally of one of two doses of Veillonella or placebo for four weeks, while again filling out both daily and weekly surveys. Finally, there will be a two week washout period with no supplementation but only daily and weekly surveys. At the end of the study, there will be a final experience survey.

Key facts

Study ID

NCT06141343

Run by

FitBiomics, Inc.

People needed

153

Starts

2023-08-01

Expected to finish

2023-11-07

Last updated by the study team

2023-11-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• FitBiomics, Inc. — New York, New York, United States

Full record on ClinicalTrials.gov

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