Safety and Tolerance of a Novel Three-Strain Probiotic in Healthy Adults

This Phase I \& II study evaluates the safety and tolerability of 8 weeks of daily supplementation with high-dose versus standard-dose of a novel three-strain probiotic. Safety and tolerability will be assessed by adverse events, safety blood profile, and vital signs. Secondary assessments include food cravings, gastrointestinal outcomes, sleep, quality of life, subjective ratings of hunger and satiety and associated hormone responses including plasma GLP-1, glucose, and insulin.

NCT Number	NCT07566884
Lead Sponsor	Pendulum Therapeutics Collaborators: Atlantia Food Clinical Trials, APC Microbiome Ireland
Conditions	Healthy Adults
Enrollment	30 participants
Start Date	2024-09-23
Primary Completion	2028-01 (estimated)
Study Completion	2028-04 (estimated)
Updated on ClinicalTrials.gov	2026-05-11