No phaseNot yet recruiting

Early Probiotic Research: Open-label Functional Intervention and Longitudinal Evaluation in Healthy Adults (ePROFILE20)

Sponsor
OneCarbon (Industry)
Enrolment
20 planned
Conditions
Probiotic Intervention; Healthy Adult Participants
Interventions
Probiotic Supplement (1C-01)
Ages
adults, older adults
Registry
NCT07841457

Full record on ClinicalTrials.gov

From the registry

This study is a pre-post, open-label pilot feasibility study designed to investigate how a food-grade probiotic supplement affects biological measurements and wellbeing in healthy adults. Participants will take one capsule daily for 1 month. During the study, participants will complete online cognitive tasks and provide blood and stool samples collected during home visits by trained staff. The samples will be analysed to explore changes in gut bacteria and other biological markers. This study aims to understand whether the supplement is well tolerated and whether measurable biological changes occur. The study does not involve any experimental drugs or invasive procedures beyond blood sampling and stool collection, and participants will not be asked to change any current prescribed medications or treatments; with eligibility exclusions applying for recent antibiotics or immunosuppressants. The supplement is being studied for research purposes only and is not intended to diagnose, treat, or prevent disease.

Primary outcomes

  • Stool metagenome

History

  1. Study completion expected

  2. Primary completion expected

  3. Expected to start

  4. Last registry update

  5. Registered