NCT02730325

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2017

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2018

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

2 years

First QC Date

February 5, 2016

Last Update Submit

November 10, 2021

Conditions

Clostridium Difficile

Keywords

CDIC. diffUlcerative ColitisUCIBDInflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Time (# of days) to resolution of diarrhea

    Group 1 \& Group 2 subjects: Stool consistency will be assessed using the BSS. Subjects will be provided a daily diary A to record the time and consistency of each bowel movement in a 24 hour period. At the Week 4 visit, the Investigator will calculate the time (# of days) to resolution of diarrhea, defined as a consecutive 24 hour period with only formed bowel movements (BSS ≤ 4), after initiation of investigational product (Day 1).

    12 weeks

Secondary Outcomes (15)

  • Incidence of recurrent CDI

    12 weeks

  • Incidence of C. difficile

    12 weeks

  • UC status measured by P-SCCAI

    4, 8 and 12 weeks

  • UC status measured by BSS

    4 weeks

  • UC status measured by Fecal calprotectin

    12 weeks

  • +10 more secondary outcomes

Study Arms (2)

SBI 10 g BID

ACTIVE COMPARATOR

Serum-derived bovine immunoglobulin/protein isolate (SBI) 10.0 grams twice per day

Other: Serum-derived bovine immunoglobulin/protein isolate (SBI)

Placebo BID

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Serum-derived bovine immunoglobulin/protein isolate (SBI)OTHER
SBI 10 g BID
PlaceboOTHER
Placebo BID

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of UC confirmed by colonoscopy and histology.
  • 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.

You may not qualify if:

  • Subjects with history of constipation within a week of the screening visit; or any serious hepatic, renal, cardiovascular, neurological or hematological disorder in the opinion of the Investigator.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Miami

Miami, Florida, 33136, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University

Chicago, Illinois, 60657, United States

Location

MeSH Terms

Conditions

Colitis, UlcerativeInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Stephen B Hanauer, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 5, 2016

First Posted

April 6, 2016

Study Start

December 1, 2015

Primary Completion

December 12, 2017

Study Completion

January 5, 2018

Last Updated

November 18, 2021

Record last verified: 2021-11

Locations

US(3)