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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.
Full 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)
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Inclusion criteria
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).
Subjects who have been admitted to the hospital more than 48 hours prior to enrollment.
Women who are pregnant.
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Interventional model
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10 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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