Clinical trial NCT02730325: To Evaluate the Impact of SBI on C. Difficile in Hospitalized UC Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Clostridium Difficile
Keywords: CDI
C. diff
Ulcerative Colitis
UC
IBD
Inflammatory Bowel Disease
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Entera Health, Inc
First posted: 2016-04-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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:

• 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)

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.

Primary outcomes:
measure: Time (# of days) to resolution of diarrhea
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of recurrent CDI
timeFrame: 12 weeks
measure: Incidence of C. difficile
timeFrame: 12 weeks
measure: UC status measured by P-SCCAI
timeFrame: 4, 8 and 12 weeks
measure: UC status measured by BSS
timeFrame: 4 weeks
measure: UC status measured by Fecal calprotectin
timeFrame: 12 weeks
measure: UC status measured by CRP
timeFrame: 12 weeks
measure: UC status measured by colectomy rate
timeFrame: 12 weeks
measure: Nutritional Status measured by pre-albumin
timeFrame: 12 weeks
measure: Nutritional Status measured by albumin
timeFrame: 12 weeks
measure: Nutritional Status measured by hand grip strength
timeFrame: 12 weeks
measure: Nutritional Status measured by fecal alpha-1 antitrypsin
timeFrame: 12 weeks
measure: Safety and Tolerability evaluated by reported and observed treatment related adverse events
timeFrame: 12 weeks
measure: Quality of Life evaluated using the SF-36
timeFrame: 12 weeks
measure: Fecal Microbiome
timeFrame: 12 weeks
measure: Length of Hospitalization
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Stephen B Hanauer, MD
role: PRINCIPAL_INVESTIGATOR
References: