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