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

• ClinicalTrials.gov Identifier: NCT03793686
• Recruitment Status: Terminated
• First Posted: January 4, 2019
• Last Update Posted: October 19, 2020
• Sponsor: Prolacta Bioscience
• Information provided by (Responsible Party): Prolacta Bioscience

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Clostridium Difficile Diarrhea	Drug: PBCLN-003; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: December 6, 2018
• Actual Primary Completion Date: September 1, 2020
• Actual Study Completion Date: September 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Characterization of Adverse Events in a dose escalation study of PBCLN-003 [ Time Frame: Up to 8 Weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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®

Contacts and Locations

Locations

United States, Idaho

Infectious Disease Specialist

Idaho Falls, Idaho, United States, 83404

Sponsors and Collaborators

Prolacta Bioscience

Investigators

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

More Information

• Responsible Party: Prolacta Bioscience
• ClinicalTrials.gov Identifier: NCT03793686
• Other Study ID Numbers: 18-CT-001
• First Posted: January 4, 2019
• Last Update Posted: October 19, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diarrhea; Signs and Symptoms, Digestive