NCT06141343

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

Project V - A Randomized Controlled Prospective Study of the Next-generation Probiotic, Veillonella Atypica FB0054, vs Placebo in Healthy Adults

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 153 (actual)
• Sponsor: FitBiomics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fatigue

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
OTHER	Placebo	Placebo will be given as the non-active study control

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-11-07
• Completion: 2023-11-07
• First posted: 2023-11-21
• Last updated: 2023-11-21

Locations

1 site across 1 country: United States