An interventional study of Serum-derived bovine immunoglobulin/protein isolate (SBI) and Placebo in Clostridium Difficile, sponsored by Northwestern University. Terminated at 3 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-11-18.
Sponsored by Northwestern University · Not applicable, Interventional, and Other
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.
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:
Secondary Objectives:
II. Hospitalized UC patients who tested negative for C. difficile at time of admission.
Primary Objective:
Secondary Objectives:
310 studies on the registry are indexed under Clostridium Infections; 50 are open to participants now.
This study's enrollment of 10 is below the median of 65 across 233 interventional studies indexed under Clostridium Infections.
Browse Clostridium Infections studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects using anti-diarrheal medications (e.g., loperamide and bismuth subsalicylate).
Serum-derived bovine immunoglobulin/protein isolate (SBI) 10.0 grams twice per day
Other: Serum-derived bovine immunoglobulin/protein isolate (SBI)
Placebo
Other: Placebo
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
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
UC status measured by CRP
Group I \& Group II subjects
Time frame: 12 weeks
UC status measured by colectomy rate
Group I \& Group II subjects
Time frame: 12 weeks
Nutritional Status measured by pre-albumin
Group I \& Group II subjects
Time frame: 12 weeks
Nutritional Status measured by albumin
Group I \& Group II subjects
Time frame: 12 weeks
Nutritional Status measured by hand grip strength
Group I \& Group II subjects
Time frame: 12 weeks
Nutritional Status measured by fecal alpha-1 antitrypsin
Group I \& Group II subjects
Time frame: 12 weeks
Safety and Tolerability evaluated by reported and observed treatment related adverse events
Group I \& Group II subjects
Time frame: 12 weeks
Quality of Life evaluated using the SF-36
Group I \& Group II subjects
Time frame: 12 weeks
Fecal Microbiome
Group I \& Group II subjects
Time frame: 12 weeks
Length of Hospitalization
Group I \& Group II subjects
Time frame: 12 weeks
This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Northwestern University