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

Clostridium Difficile Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02730325
• Other study ID #: STU00200335
• Status: Terminated
• Phase: N/A
• Start date: December 2015
• Est. completion date: January 5, 2018

Study information

• Verified date: November 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 5, 2018
• Est. primary completion date: December 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clostridium Difficile
• Clostridium Infections

Intervention

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

• Placebo

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Rush University	Chicago	Illinois
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Entera Health, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.	12 weeks
Secondary	UC status measured by P-SCCAI	Group I & Group II subjects	4, 8 and 12 weeks
Secondary	UC status measured by BSS	Group I & Group II subjects	4 weeks
Secondary	UC status measured by Fecal calprotectin	Group I & Group II subjects	12 weeks
Secondary	UC status measured by CRP	Group I & Group II subjects	12 weeks
Secondary	UC status measured by colectomy rate	Group I & Group II subjects	12 weeks
Secondary	Nutritional Status measured by pre-albumin	Group I & Group II subjects	12 weeks
Secondary	Nutritional Status measured by albumin	Group I & Group II subjects	12 weeks
Secondary	Nutritional Status measured by hand grip strength	Group I & Group II subjects	12 weeks
Secondary	Nutritional Status measured by fecal alpha-1 antitrypsin	Group I & Group II subjects	12 weeks
Secondary	Safety and Tolerability evaluated by reported and observed treatment related adverse events	Group I & Group II subjects	12 weeks
Secondary	Quality of Life evaluated using the SF-36	Group I & Group II subjects	12 weeks
Secondary	Fecal Microbiome	Group I & Group II subjects	12 weeks
Secondary	Length of Hospitalization	Group I & Group II subjects	12 weeks