NCT02730325

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

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Impact of Serum-derived Bovine Immunoglobulin/Protein Isolate (SBI) on Clostridium Difficile (C. Difficile) Infection (CDI) in Hospitalized Ulcerative Colitis (UC) Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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)

Conditions

• Clostridium Difficile

Interventions

Type	Name	Description
OTHER	Serum-derived bovine immunoglobulin/protein isolate (SBI)
OTHER	Placebo

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-12-12
• Completion: 2018-01-05
• First posted: 2016-04-06
• Last updated: 2021-11-18

Locations

3 sites across 1 country: United States