To Evaluate the Impact of SBI on C. Difficile in Hospitalized UC Patients

The effects of serum-derived bovine immunoglobulin/protein isolate (SBI) will be evaluated
and compared to matching placebo in two distinct patient populations:

I. Hospitalized ulcerative colitis (UC) patients who tested positive for Clostridium
difficile (C. difficile) at time of admission and are receiving vancomycin.

Primary Objective:

• To evaluate the effect of SBI on time (# of days) to resolution of diarrhea, defined as a
consecutive 24 hour period with only formed bowel movements (Bristol Stool Scale (BSS) ≤ 4)
in this patient population

Secondary Objectives:

- To evaluate the ability of SBI to decrease the incidence of recurrent C. difficile
infection (CDI) following successful treatment with vancomycin.

- To evaluate the effect of SBI on UC status

- To evaluate the effect of SBI on nutritional status

- To evaluate the safety and tolerability of SBI

- To evaluate the effect of SBI on subjects' quality of life (QOL)

- To investigate the effect of SBI in fecal microbiome

- To evaluate the length of hospitalization (time of hospitalization to time of
discharge)

II. Hospitalized UC patients who tested negative for C. difficile at time of admission.

Primary Objective:

• To evaluate the effect of SBI on time (# of days) to resolution of diarrhea, defined as a
consecutive 24 hour period with only formed bowel movements (Bristol Stool Scale (BSS) ≤ 4)
in this patient population

Secondary Objectives:

- To evaluate the effect of SBI in decreasing the incidence of CDI

- To evaluate the effect of SBI on UC status

- To evaluate the effect of SBI on nutritional status

- To evaluate the safety and tolerability of SBI

- To evaluate the effect of SBI on subjects' QOL

- To investigate the effect of SBI in fecal microbiome

- To evaluate the length of hospitalization (time of hospitalization to time of
discharge)

Inclusion Criteria:

- Diagnosis of UC confirmed by colonoscopy and histology.

- Confirmed active UC upon hospital admission, defined by a partial Mayo Score of ≥ 3
with a stool frequency subscore of ≥ 2.

- Concomitant therapy for UC will be permitted. Subjects will be instructed not to make
any medication changes after hospital discharge before first discussing with the
Investigator.

- Eligible subjects will be assigned to one of two different and independent patient
groups based on C. difficile status as determined by polymerase chain reaction (PCR)
assay.

Exclusion Criteria:

- Subjects positive for enteric pathogens aside from C. difficile at screening visit.

- Subjects with history of constipation within a week of the screening visit; or any
serious hepatic, renal, cardiovascular, neurological or hematological disorder in the
opinion of the Investigator.

- Subjects with history of drug or alcohol abuse, history of psychiatric disorders,
known allergy or hypersensitivity to beef or any component of SBI.

- Subjects with a history of antibiotic treatment within the 4 weeks prior to
enrollment.

- Subjects using anti-diarrheal medications (e.g., loperamide and bismuth
subsalicylate).

- Note: anti-diarrheal medications will be prohibited throughout the study.

- Subjects who have been admitted to the hospital more than 48 hours prior to
enrollment.

- Women who are pregnant.