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

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

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 recurrent 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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 Recurrent C. Difficile-associated Diarrhea
Actual Study Start Date : December 6, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Experimental
PBCLN-003, daily in 3 divided oral doses for 7 days, 3 ascending dose cohorts
Drug: PBCLN-003
Investigational drug

Placebo Comparator: Placebo
Placebo, daily in 3 divided oral doses for 7 days, 3 ascending dose cohorts
Drug: Placebo
Placebo




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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent CDAD
  • Enrollment episode of CDAD diagnosed based on > 3 loose stools per day and detection of CD toxin by nucleic acid amplification tests (NAAT) and 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(metronidazole, vancomycin, fidaxomicin)
  • BMI > 18.5 and < 40
  • Age 18 to 80 years
  • 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®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793686


Contacts
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Contact: Kim Long (888) 776-5228 info@prolacta.com

Locations
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United States, Idaho
Infectious Disease Specialist Recruiting
Idaho Falls, Idaho, United States, 83404
Sponsors and Collaborators
Prolacta Bioscience
Investigators
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Study Director: David J Rechtman, MD Vice President, Medical Affairs, Prolacta Bioscience

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Responsible Party: Prolacta Bioscience
ClinicalTrials.gov Identifier: NCT03793686     History of Changes
Other Study ID Numbers: 18-CT-001
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents