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

NCT03793686 | Terminated Phase 1 FDA Drug

• 1 other identifier: 18-CT-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental

EXPERIMENTAL

PBCLN-003, daily in 3 divided oral doses for 7 days, 2 ascending dose cohorts

Drug: PBCLN-003

Placebo

PLACEBO COMPARATOR

Placebo, daily in 3 divided oral doses for 7 days, 2 ascending dose cohorts

Drug: Placebo

Interventions

PBCLN-003 DRUG

Investigational drug

Experimental

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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®

Sponsors & Collaborators

• Prolacta Bioscience: lead

Study Sites (1)

Infectious Disease Specialist

Idaho Falls, Idaho, 83404, United States

Location

Study Officials

• David J Rechtman, MD

  Vice President, Medical Affairs, Prolacta Bioscience

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 4, 2019
• Study Start: December 6, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)