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

NCT03793686 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-10-19

No results posted yet for this study

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.

Conditions

  • Clostridium Difficile Diarrhea

Interventions

DRUG

PBCLN-003

Investigational drug

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Prolacta Bioscience

    lead INDUSTRY

Principal Investigators

  • David J Rechtman, MD · Vice President, Medical Affairs, Prolacta Bioscience

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2020-09-01
Completion
2020-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03793686 on ClinicalTrials.gov