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

NCT06141343 | Completed

• 1 other identifier: FB004
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue

Outcome Measures

Primary Outcomes (3)

• Changes in reported physical fatigue

  The majority of primary endpoints for this study are questions on the survey which consist of rating scales (generally 1-5 or 1-9). Significant differences between groups for these endpoints will be assessed using an independent T test or Mann-Whitney U test depending on the observed distribution of the data. For significant changes over time within the same group, a dependent T test will be used.

  8 weeks

• Change in mental / emotional fatigue

  The majority of primary endpoints for this study are questions on the survey which consist of rating scales (generally 1-5 or 1-9). Significant differences between groups for these endpoints will be assessed using an independent T test or Mann-Whitney U test depending on the observed distribution of the data. For significant changes over time within the same group, a dependent T test will be used.

  8 weeks

• Change in Multi-dimensional Fatigue Inventory Questionnaire

  The majority of primary endpoints for this study are questions on the survey which consist of rating scales (generally 1-5 or 1-9). Significant differences between groups for these endpoints will be assessed using an independent T test or Mann-Whitney U test depending on the observed distribution of the data. For significant changes over time within the same group, a dependent T test will be used.

  8 weeks

Study Arms (2)

Veillonella atypica FB0054

Active ingredient dietary supplement group

Dietary Supplement: Veillonella atypica FB0054

Placebo

No active ingredient

Other: Placebo

Interventions

Veillonella atypica FB0054 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.

Veillonella atypica FB0054

Placebo OTHER

Placebo will be given as the non-active study control

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• FitBiomics, Inc.: lead
• People Science, Inc.: collaborator

Study Sites (1)

FitBiomics, Inc.

New York, New York, 10014, United States

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Scheiman, PhD

  FitBiomics, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: November 21, 2023
• Study Start: August 1, 2023
• Primary Completion: November 7, 2023
• Study Completion: November 7, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

US (1)