A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea

Summary

This Phase I double blind, randomized clinical study to evaluate the safety of human milk oligosaccharides (HMO) is designed to assess the safety and dosage ranging of PBCLN-003 in adults with Clostridium difficile-associated diarrhea (CDAD). Within 3 dose cohort, subjects will be randomized in a 3:1 ratio to receive PBCLN-003 or placebo.

Timeline

Start

2018-12-06

Primary completion

2020-09-01

Completion

2020-09-01

Outcome

Outcome not reported

Stopped (Enrollment): “Unable to enroll subjects”

Drugs

Indications