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Trial record 6 of 21 for:    "Bacterial Infectious Disease" | "Guaifenesin"

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

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ClinicalTrials.gov Identifier: NCT02730325
Recruitment Status : Unknown
Verified September 2016 by Stephen Hanauer, Northwestern University.
Recruitment status was:  Active, not recruiting
First Posted : April 6, 2016
Last Update Posted : June 6, 2017
Sponsor:
Collaborator:
Entera Health, Inc
Information provided by (Responsible Party):
Stephen Hanauer, 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.


Condition or disease Intervention/treatment Phase
Clostridium Difficile Other: Serum-derived bovine immunoglobulin/protein isolate (SBI) Other: Placebo Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Study Start Date : December 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: SBI 10 g BID
Serum-derived bovine immunoglobulin/protein isolate (SBI) 10.0 grams twice per day
Other: Serum-derived bovine immunoglobulin/protein isolate (SBI)
Placebo Comparator: Placebo BID
Placebo
Other: Placebo



Primary Outcome Measures :
  1. Time (# of days) to resolution of diarrhea [ Time Frame: 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 :
  1. Incidence of recurrent CDI [ Time Frame: 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.

  2. Incidence of C. difficile [ Time Frame: 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.

  3. UC status measured by P-SCCAI [ Time Frame: 4, 8 and 12 weeks ]
    Group I & Group II subjects

  4. UC status measured by BSS [ Time Frame: 4 weeks ]
    Group I & Group II subjects

  5. UC status measured by Fecal calprotectin [ Time Frame: 12 weeks ]
    Group I & Group II subjects

  6. UC status measured by CRP [ Time Frame: 12 weeks ]
    Group I & Group II subjects

  7. UC status measured by colectomy rate [ Time Frame: 12 weeks ]
    Group I & Group II subjects

  8. Nutritional Status measured by pre-albumin [ Time Frame: 12 weeks ]
    Group I & Group II subjects

  9. Nutritional Status measured by albumin [ Time Frame: 12 weeks ]
    Group I & Group II subjects

  10. Nutritional Status measured by hand grip strength [ Time Frame: 12 weeks ]
    Group I & Group II subjects

  11. Nutritional Status measured by fecal alpha-1 antitrypsin [ Time Frame: 12 weeks ]
    Group I & Group II subjects

  12. Safety and Tolerability evaluated by reported and observed treatment related adverse events [ Time Frame: 12 weeks ]
    Group I & Group II subjects

  13. Quality of Life evaluated using the SF-36 [ Time Frame: 12 weeks ]
    Group I & Group II subjects

  14. Fecal Microbiome [ Time Frame: 12 weeks ]
    Group I & Group II subjects

  15. Length of Hospitalization [ Time Frame: 12 weeks ]
    Group I & Group II subjects



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730325


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Rush University
Chicago, Illinois, United States, 60657
Sponsors and Collaborators
Northwestern University
Entera Health, Inc
Investigators
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Principal Investigator: Stephen B Hanauer, MD Northwestern University

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Responsible Party: Stephen Hanauer, Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT02730325     History of Changes
Other Study ID Numbers: STU00200335
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: September 2016

Keywords provided by Stephen Hanauer, Northwestern University:
CDI
C. diff
Ulcerative Colitis
UC
IBD
Inflammatory Bowel Disease

Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs