To Evaluate the Impact of SBI on C. Difficile in Hospital... | NCT02730325

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

NCT02730325

Sponsor

Northwestern University

Status

Terminated

Last Update Posted

Nov 18, 2021Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Clostridium Difficile

Interventions

Serum-derived bovine immunoglobulin/protein isolate (SBI)
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study terminated due to limited enrollment.

Expanded Access Info

Start Date

Dec 2015Actual

Primary Completion Date

Dec 12, 2017Actual

Completion Date

Jan 5, 2018Actual

First Submitted Date

Feb 5, 2016

First Submission Date that Met QC Criteria

Mar 31, 2016

First Posted Date

Apr 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2021

Last Update Posted Date

Nov 18, 2021Actual

Name	Class
Entera Health, Inc	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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:

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Serum-derived bovine immunoglobulin/protein isolate (SBI)	Other		SBI 10 g BID
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Incidence of recurrent CDI	Group I subjects: if subject develops diarrhea (≥ 3 unformed stools in 24h period) at any point following successful treatment with vancomycin. The presence of C. difficile will be determined by PCR or GDH/Toxin EIA.	12 weeks
Incidence of C. difficile

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami		Miami	Florida	33136	United States
Northwestern University

ID	Term
D003093	Colitis, Ulcerative
D015212	Inflammatory Bowel Diseases

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases