Status
Conditions
Treatments
About
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.
II. Hospitalized UC patients who tested negative for C. difficile at time of admission.
Full description
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:
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:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
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).
Subjects who have been admitted to the hospital more than 48 hours prior to enrollment.
Women who are pregnant.
Primary purpose
Allocation
Interventional model
Masking
10 participants in 2 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal