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

Northwestern University10 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Clostridium Difficile

Interventions

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

PlaceboOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (3)

University of Miami

Miami, Florida, United States

Northwestern University

Chicago, Illinois, United States

Rush University

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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).

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 12 weeks

Incidence of C. difficile

Group II subjects: Incidence of C. difficile will be determined following 12 weeks of investigational product. Symptoms will be assessed by daily diary and by P SCCAI at each study visit. Should the subject develop diarrhea (≥ 3 unformed stools in 24h period) at any point during the study participation, he/she will return to the clinic and be tested for C. difficile by PCR or GDH/Toxin EIA.

Time frame: 12 weeks

UC status measured by P-SCCAI

Group I \& Group II subjects

Time frame: 4, 8 and 12 weeks

UC status measured by BSS

Group I \& Group II subjects

Time frame: 4 weeks

UC status measured by Fecal calprotectin

Group I \& Group II subjects

Time frame: 12 weeks

Data from ClinicalTrials.gov

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