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ACTIVE NOT RECRUITING
NCT07566884
NA

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

Sponsor: Pendulum Therapeutics

View on ClinicalTrials.gov

Summary

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.

Official title: A Two-Phase Study on the Safety and Tolerance of a Novel Probiotic in Healthy Adults: Open-Label and Double-Blind, Placebo-Controlled Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-09-23

Completion Date

2028-04

Last Updated

2026-05-11

Healthy Volunteers

Yes

Conditions

Interventions

DIETARY_SUPPLEMENT

Three-Strain Probiotic

≥ 500 million AFU of Clostridium butyricum strain WB-STR-0006, Akkermansia muciniphila strain WB-STR-0001, Bifidobacterium infantis Bi-26TM, 174 mg chicory inulin (prebiotic), 19mg Microcrystalline Cellulose MCC, 4mg L-Leucine, and 3mg Silica (excipients) to be taken once daily with food

DIETARY_SUPPLEMENT

Phase 2 - Placebo

Phase 2 - Matching Placebo

Locations (1)

Atlantia Clinical Trials

Cork, Ireland