Finding studies
Finding studies
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Lead
Northwestern University
With
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)
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
