NCT07457242

Probiotic Research: Open-label Functional Intervention and Longitudinal Evaluation in Healthy Adults

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Healthspan Biotics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is a pre-post, open-label cohort 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 either 1 month or 6 months. 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. Participants will be invited to participate in a follow-up visit to assess long-term effects.

Conditions

• Cognition
• Multiomics
• Microbiome Analysis
• Metabolome
• Proteome
• Metagenome
• Probiotics Supplement
• Gut-brain Axis
• Pilot Study
• Adult
• Sleep

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic Supplementation (Lactobacillus plantarum)	This probiotic is a proprietary food-grade supplement that is not yet commercially available or CE-marked.

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2026-03-09
• Last updated: 2026-03-09