Clostridium DifficileNCT02730325
To Evaluate the Impact of SBI on C. Difficile in Hospitalized UC Patients
A study testing Serum-derived bovine immunoglobulin/protein isolate (SBI) in people with Clostridium Difficile, run by Northwestern University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- Serum-derived bovine immunoglobulin/protein isolate (SBI)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2015to 5 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University
Chicago, Illinois, 60611
Rush University
Chicago, Illinois, 60657
University of Miami
Miami, Florida, 33136
About this study
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
The effects of serum-derived bovine immunoglobulin/protein isolate (SBI) will be evaluated and compared to matching placebo in two distinct patient populations:
- 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.
Read the 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:
- 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)
- Conditions
- Clostridium Difficile
- Being tested
- Serum-derived bovine immunoglobulin/protein isolate (SBI), Placebo
- Keywords
- CDI, C. diff, Ulcerative Colitis, UC, IBD, Inflammatory Bowel Disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum-derived bovine immunoglobulin/protein isolate (SBI)Other
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| SBI 10 g BID | Active comparator | Serum-derived bovine immunoglobulin/protein isolate (SBI) 10.0 grams twice per day Receives: Other: Serum-derived bovine immunoglobulin/protein isolate (SBI) |
| Placebo BID | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (15)
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.
Measured: 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.
Measured: 12 weeks
UC status measured by P-SCCAI
Group I \& Group II subjects
Measured: 4, 8 and 12 weeks
UC status measured by BSS
Group I \& Group II subjects
Measured: 4 weeks
UC status measured by Fecal calprotectin
Group I \& Group II subjects
Measured: 12 weeks
UC status measured by CRP
Group I \& Group II subjects
Measured: 12 weeks
UC status measured by colectomy rate
Group I \& Group II subjects
Measured: 12 weeks
Nutritional Status measured by pre-albumin
Group I \& Group II subjects
Measured: 12 weeks
Nutritional Status measured by albumin
Group I \& Group II subjects
Measured: 12 weeks
Nutritional Status measured by hand grip strength
Group I \& Group II subjects
Measured: 12 weeks
Nutritional Status measured by fecal alpha-1 antitrypsin
Group I \& Group II subjects
Measured: 12 weeks
Safety and Tolerability evaluated by reported and observed treatment related adverse events
Group I \& Group II subjects
Measured: 12 weeks
Quality of Life evaluated using the SF-36
Group I \& Group II subjects
Measured: 12 weeks
Fecal Microbiome
Group I \& Group II subjects
Measured: 12 weeks
Length of Hospitalization
Group I \& Group II subjects
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startDec 2015
- Primary completion12 Dec 2017
- Study completion5 Jan 2018
Why it stopped: Study terminated due to limited enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Entera Health, Inc
- Responsible party
- Principal investigator, Stephen Hanauer, Northwestern University
- Investigators
- Stephen B Hanauer, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730325
- Sponsor's protocol ID
- STU00200335
- Status last verified
- Nov 2021
- First submitted
- 5 Feb 2016
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02730325
- Acronym / sponsor ID
- STU00200335
- Conditions
- Clostridium Difficile
- Keywords
- CDI, C. diff, Ulcerative Colitis, UC, IBD, Inflammatory Bowel Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to limited enrollment.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Entera Health, Inc
- Study start
- Dec 2015 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effects of serum-derived bovine immunoglobulin/protein isolate (SBI) will be evaluated and compared to matching placebo in two distinct patient populations:
- 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:
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBI 10 g BID | Active comparator | Other: Serum-derived bovine immunoglobulin/protein isolate (SBI)Serum-derived bovine immunoglobulin/protein isolate (SBI) 10.0 grams twice per day |
| Placebo BID | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum-derived bovine immunoglobulin/protein isolate (SBI) | Other | SBI 10 g BID |
| Placebo | Other | Placebo BID |
Primary outcome
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).
15 secondary outcomes
Incidence of recurrent CDI
Time frame: 12 weeks
Incidence of C. difficile
Time frame: 12 weeks
UC status measured by P-SCCAI
Time frame: 4, 8 and 12 weeks
UC status measured by BSS
Time frame: 4 weeks
UC status measured by Fecal calprotectin
Time frame: 12 weeks
UC status measured by CRP
Time frame: 12 weeks
UC status measured by colectomy rate
Time frame: 12 weeks
Nutritional Status measured by pre-albumin
Time frame: 12 weeks
Nutritional Status measured by albumin
Time frame: 12 weeks
Nutritional Status measured by hand grip strength
Time frame: 12 weeks
Nutritional Status measured by fecal alpha-1 antitrypsin
Time frame: 12 weeks
Safety and Tolerability evaluated by reported and observed treatment related adverse events
Time frame: 12 weeks
Quality of Life evaluated using the SF-36
Time frame: 12 weeks
Fecal Microbiome
Time frame: 12 weeks
Length of Hospitalization
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Study terminated due to limited enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen B Hanauer, MD principal investigator
Northwestern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum-derived bovine immunoglobulin/protein isolate (SBI) in people with Clostridium Difficile, run by Northwestern University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to limited enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (# of days) to resolution of diarrhea (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.