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

Not Applicable

Terminated

• Conditions: Clostridium Difficile
• Interventions: Other: Serum-derived bovine immunoglobulin/protein isolate (SBI); Other: Placebo

• Registration Number: NCT02730325
• Lead Sponsor: Northwestern University

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)

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Primary Completion: 2017-12-12
• Study Completion: 2018-01-05
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-10
• Last Update Posted: 2021-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SBI 10 g BID	Serum-derived bovine immunoglobulin/protein isolate (SBI)	Serum-derived bovine immunoglobulin/protein isolate (SBI) 10.0 grams twice per day
Placebo BID	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Time (# of days) to resolution of diarrhea	12 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Length of Hospitalization	12 weeks	Group I \& Group II subjects
Nutritional Status measured by pre-albumin	12 weeks	Group I \& Group II subjects
Safety and Tolerability evaluated by reported and observed treatment related adverse events	12 weeks	Group I \& Group II subjects
Incidence of recurrent CDI	12 weeks	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.
UC status measured by P-SCCAI	4, 8 and 12 weeks	Group I \& Group II subjects
UC status measured by CRP	12 weeks	Group I \& Group II subjects
Nutritional Status measured by albumin	12 weeks	Group I \& Group II subjects
Nutritional Status measured by hand grip strength	12 weeks	Group I \& Group II subjects
Fecal Microbiome	12 weeks	Group I \& Group II subjects
Incidence of C. difficile	12 weeks	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.
UC status measured by BSS	4 weeks	Group I \& Group II subjects
UC status measured by Fecal calprotectin	12 weeks	Group I \& Group II subjects
UC status measured by colectomy rate	12 weeks	Group I \& Group II subjects
Quality of Life evaluated using the SF-36	12 weeks	Group I \& Group II subjects
Nutritional Status measured by fecal alpha-1 antitrypsin	12 weeks	Group I \& Group II subjects

Trial Locations

Locations (3)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Rush University; 🇺🇸 Chicago, Illinois, United States