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

A Phase 1 Double Blind, Randomized Clinical Study to Evaluate the Safety of Human Milk Oligosaccharides Following Antibiotic Therapy in Subjects With C. Difficile-associated Diarrhea

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.

Study Overview

• Status: Terminated
• Conditions: Clostridium Difficile Diarrhea
• Intervention / Treatment: Drug: Placebo; Drug: PBCLN-003

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Infectious Disease Specialist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Enrollment episode of CDAD diagnosed based on > 3 loose stools per day and detection of CD toxin by nucleic acid amplification tests (NAAT), EIA or GDH
• Mild to moderate CDAD during enrollment episode (per Society of Hospital Epidemiologists of America (SHEA)/lnfectious Disease Society of America(ISDA) criteria)
• Current therapy with standard of care antibiotics for recurrent CDAD(vancomycin, metronidazole, fidaxomicin)
• BMI > 18.5 and < 40
• Age 18 years or older
• Agreement to adhere to the study protocol
• Informed consent is obtained
• Women who are capable of bearing children must have a negative pregnancy test at the time of screening
• Female subjects of childbearing potential must use birth control (defined as oral or injectable contraceptives, intrauterine devices, surgical sterilization or a combination of a condom and spermicide) during the study period and for up to 8 weeks after the first drug of study.

Exclusion Criteria:

• Severe CDAD during enrollment episode (per SHEA/ISDA criteria) characterized as follows:

  • History of five (5) or more recurrences of CDAD within the past 12 months prior to potential study enrollment
  • History of fecal microbiome transplant or other microbiome directed experimental intervention for CDAD
  • History (ever) of CD complicating inflammatory bowel disease (Crohn's disease, ulcerative colitis), or history of bowel resection surgery (other than uncomplicated appendectomy) or history of other infectious diarrhea or diarrhea of unknown etiology since the initial episode of CDAD
• Clinically immunocompromised due to any primary immune or autoimmune deficiency, as a result of chronic disease, cancer or medication used to treat these diseases
• Initiating a new diet or weight loss amounting to 10% within two weeks prior to date of study entry
• Enrolled in another clinical study for the therapy of CDAD or affecting nutritional management during the study period
• Enrolled or has been enrolled in another experimental (IND) study within two weeks prior to date of study entry
• Is pregnant or lactating
• History of swallowing difficulties, including dysphagia or odynophagia for liquids or solids
• Use of any Probiotics (any formulation) within the two weeks prior to date of study entry

• New, or a change in the consumption of the following prescription medications or over-the-counter (OTC) medications within two weeks prior to date of study entry:

  • Proton pump inhibitors (for example: Prilosec®, Nexium®)
  • Histamine-2 receptor antagonists (for example: Zantac®, Pepcid®)
• Consumption of the following prescription medications during the current enrollment episode: • Bezlotuxamab/Zinplava®

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; PBCLN-003, daily in 3 divided oral doses for 7 days, 2 ascending dose cohorts	Drug: PBCLN-003; Investigational drug
Placebo Comparator: Placebo; Placebo, daily in 3 divided oral doses for 7 days, 2 ascending dose cohorts	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterization of Adverse Events in a dose escalation study of PBCLN-003	Comparison of adverse event reporting and grading results between groups using physical exams, safety related blood tests, and urinalysis, adverse event reports, and subject complaint logs.	Up to 8 Weeks

Collaborators and Investigators

• Sponsor: Prolacta Bioscience
• Investigators: Study Director: David J Rechtman, MD, Vice President, Medical Affairs, Prolacta Bioscience

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2018
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: 18-CT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No