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

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

Tracking Information
First Submitted Date  ICMJE December 27, 2018
First Posted Date  ICMJE January 4, 2019
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE December 6, 2018
Actual Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
Dosage ranging of PBCLN-003 [ Time Frame: Up to 8 Weeks ]
Assess the dosage ranging of PBCLN-003 in adults with recurrent Clostridium difficile-associated diarrhea (CDAD).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Clostridium Difficile Diarrhea
Intervention  ICMJE
  • Drug: PBCLN-003
    Investigational drug
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Experimental
    PBCLN-003, daily in 3 divided oral doses for 7 days, 2 ascending dose cohorts
    Intervention: Drug: PBCLN-003
  • Placebo Comparator: Placebo
    Placebo, daily in 3 divided oral doses for 7 days, 2 ascending dose cohorts
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 13, 2020)
26
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2019)
48
Actual Study Completion Date  ICMJE September 1, 2020
Actual Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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®
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03793686
Other Study ID Numbers  ICMJE 18-CT-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prolacta Bioscience
Study Sponsor  ICMJE Prolacta Bioscience
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David J Rechtman, MD Vice President, Medical Affairs, Prolacta Bioscience
PRS Account Prolacta Bioscience
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP