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

NCT02730325 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-11-18

No results posted yet for this study

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.

Conditions

  • Clostridium Difficile

Interventions

OTHER

Serum-derived bovine immunoglobulin/protein isolate (SBI)

OTHER

Placebo

Sponsors & Collaborators

Principal Investigators

  • Stephen B Hanauer, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-12-12
Completion
2018-01-05

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02730325 on ClinicalTrials.gov