To Evaluate the Impact of SBI on C. Difficile in Hospitalized UC Patients
NCT ID: NCT02730325
Last Updated: 2021-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2015-12-31
2018-01-05
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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SBI 10 g BID
Serum-derived bovine immunoglobulin/protein isolate (SBI) 10.0 grams twice per day
Serum-derived bovine immunoglobulin/protein isolate (SBI)
Placebo BID
Placebo
Placebo
Interventions
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Serum-derived bovine immunoglobulin/protein isolate (SBI)
Placebo
Eligibility Criteria
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Inclusion Criteria
* Confirmed active UC upon hospital admission, defined by a partial Mayo Score of ≥ 3 with a stool frequency subscore of ≥ 2.
* Concomitant therapy for UC will be permitted. Subjects will be instructed not to make any medication changes after hospital discharge before first discussing with the Investigator.
* Eligible subjects will be assigned to one of two different and independent patient groups based on C. difficile status as determined by clinical symptoms with diarrhea and laboratory tests: either a polymerase chain reaction (PCR) assay or glutamate dehydrogenase (GDH) screening test used in two- or three-step algorithm with subsequent toxin A and B EIA testing.
Exclusion Criteria
* 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).
* Note: anti-diarrheal medications will be prohibited throughout the study.
* Subjects who have been admitted to the hospital more than 48 hours prior to enrollment.
* Women who are pregnant.
18 Years
85 Years
ALL
No
Sponsors
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Entera Health, Inc
INDUSTRY
Northwestern University
OTHER
Responsible Party
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Stephen Hanauer
Professor of Medicine
Principal Investigators
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Stephen B Hanauer, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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University of Miami
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
Rush University
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU00200335
Identifier Type: -
Identifier Source: org_study_id