Clinical trial NCT06141343: A Study of the Next-generation Probiotic, Veillonella Atypica FB0054 vs Placebo
Official title: Project V - A Randomized Controlled Prospective Study of the Next-generation Probiotic, Veillonella Atypica FB0054, vs Placebo in Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue
Lead sponsor: FitBiomics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: People Science, Inc.
First posted: 2023-11-21
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in this study will be healthy adults interested in using Veillonella to reduce fatigue and increase energy. Subjects will be excluded from the study if they have conditions, diseases, or medications that could result in increased likelihood of AEs related to Veillonella use.

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 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.

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 improve endurance compared to placebo. In mouse studies, those mice who supplemented with V. atypica ran 13% longer in a run-to-exhaustion test than those mice who were given placebo. Furthermore, in a randomized controlled crossover pilot study, the investigators could show that Veillonella prevented 78.7% of the performance decline observed in the placebo group in a run-to-exhaustion model. The investigators have also conducted experiments that have resulted in this product being deemed Generally Regarded As Safe (GRAS).

Therefore, the investigators believe the Veillonella is safe and likely to provide significant benefits in terms of improved endurance, increased energy, and decreased fatigue. This research study is designed to test that hypothesis. FitBiomics is sponsoring this study to confirm these effects in a broader population. FitBiomics is the first company to develop this type of bacteria as a probiotic, and this will be the largest study testing the safety and efficacy of this probiotic.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Changes in reported physical fatigue
timeFrame: 8 weeks
measure: Change in mental / emotional fatigue
timeFrame: 8 weeks
measure: Change in Multi-dimensional Fatigue Inventory Questionnaire
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: FitBiomics, Inc.
state: New York
Study officials:
affiliation: FitBiomics, Inc.
name: Jonathan Scheiman, PhD
role: PRINCIPAL_INVESTIGATOR
References: