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

Status Terminated

Clinical Trial Summary

Clinical Trial 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: - 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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02730325
Study type	Interventional
Source	Northwestern University
Contact
Status	Terminated
Phase	N/A
Start date	December 2015
Completion date	January 5, 2018

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