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

NCT ID: NCT06141343

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2023-11-07

Brief Summary

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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

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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.

Conditions

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Fatigue

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Veillonella atypica FB0054

Active ingredient dietary supplement group

Veillonella atypica FB0054

Intervention Type DIETARY_SUPPLEMENT

Veillonella contains Veillonella atypica FB0054 as the active ingredient with microcrystalline cellulose and hypromellose as excipients. The two doses are 15 billion cfu (high dose) and 7.5 billion cfu (low dose). Placebo capsules contain microcrystalline cellulose and hypromellose. Both Veillonella and placebo are encapsulated in acid-resistant capsules to improve delivery to the large intestine, which participants will take orally at home on a daily basis for four weeks.

Placebo

No active ingredient

Placebo

Intervention Type OTHER

Placebo will be given as the non-active study control

Interventions

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Veillonella atypica FB0054

Veillonella contains Veillonella atypica FB0054 as the active ingredient with microcrystalline cellulose and hypromellose as excipients. The two doses are 15 billion cfu (high dose) and 7.5 billion cfu (low dose). Placebo capsules contain microcrystalline cellulose and hypromellose. Both Veillonella and placebo are encapsulated in acid-resistant capsules to improve delivery to the large intestine, which participants will take orally at home on a daily basis for four weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo will be given as the non-active study control

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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People Science, Inc.

INDUSTRY

Sponsor Role collaborator

FitBiomics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Scheiman, PhD

Role: PRINCIPAL_INVESTIGATOR

FitBiomics, Inc.

Locations

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FitBiomics, Inc.

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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FB004

Identifier Type: -

Identifier Source: org_study_id