Inflammatory Bowel DiseasesPhase 4NCT04626947
Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
A Phase 4 study testing Bezlotoxumab in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by David Binion, MD at 1 site in United States.
Trial summary
The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Bezlotoxumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2021to 31 May 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old
- active CDI receiving therapy
- diagnosis of IBD
- and history of CDI.
Who cannot join
- <18 years old
- no IBD
- no CDI
- history of colectomy
- history of preexisting congestive heart failure
- pregnant or nursing women
- TCP<50
- past cardiac history.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.
Read the detailed description
Bezlotoxumab is administered during a course of antibiotic therapy. The dose is administered as one time treatment. Patients will receive 10 mg/kg IV over 60 minutes as a single dose via central line.
- Being tested
- Bezlotoxumab
- Keywords
- C.diff, C. difficile, IBD, UC, Bezlotoxumab, Recurrent C. diff
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BezlotoxumabBiological
Bezlotoxumab infusion
| Study group | Role | What they receive |
|---|---|---|
| Open label | Other | Single arm Receives: Biological: Bezlotoxumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Recurrent C. Diff Infection at 90 Days
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
Measured: 90 days
Number of Participants With Recurrent C. Diff Infection at 12 Months
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
Measured: 12 months
Number of Participants With Recurrent C. Diff Infection at 24 Months
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
Measured: 24 months
Secondary outcomes (10)
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 90 Days
Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 90 days from receiving Bezlotuxumab.
Measured: 90 days
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 12 Months
Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 12 months from receiving Bezlotuxumab
Measured: 12 months
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 24 Months
Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 24 months from receiving Bezlotuxumab
Measured: 24 months
Quality of Life and Disease Activity Scores of Participants at Study Baseline
Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission.
Measured: Index visit
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 90 Days
Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission.
Measured: 90 Days
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 12 Months
Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission.
Measured: 12 months
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 24 Months
Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission.
Measured: 24 months
Rates of Health Care Utilization After Bezlotuxumab Infusion 90 Days
Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 90 Days.
Measured: 90 Days
Rates of Health Care Utilization After Bezlotuxumab Infusion 12 Months
Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 12 months
Measured: 12 months
Rates of Health Care Utilization After Bezlotuxumab Infusion 24 Months
Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start14 Oct 2021
- Primary completion24 Apr 2024
- Study completion31 May 2024
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Binion, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, David Binion, MD, University of Pittsburgh
- Investigators
- David Binion, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626947
- Sponsor's protocol ID
- STUDY19100301
- Status last verified
- Jun 2025
- First submitted
- 29 Sep 2020
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
- ClinicalTrials.gov ID
- NCT04626947
- Acronym / sponsor ID
- STUDY19100301
- Keywords
- C.diff, C. difficile, IBD, UC, Bezlotoxumab, Recurrent C. diff
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 19 participants (actual)
- Lead sponsor
- David Binion, MDUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Posted 5 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.
Detailed description
Bezlotoxumab is administered during a course of antibiotic therapy. The dose is administered as one time treatment. Patients will receive 10 mg/kg IV over 60 minutes as a single dose via central line.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label | Other | Biological: BezlotoxumabSingle arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years old
- active CDI receiving therapy
- diagnosis of IBD
- and history of CDI.
Key exclusion criteria (8 listed)
- <18 years old
- no IBD
- no CDI
- history of colectomy
- history of preexisting congestive heart failure
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 |
|---|---|---|
| BezlotoxumabBezlotoxumab infusion | Biological | Open label |
Primary outcome
Number of Participants With Recurrent C. Diff Infection at 90 Days
Time frame: 90 days
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
Number of Participants With Recurrent C. Diff Infection at 12 Months
Time frame: 12 months
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
Number of Participants With Recurrent C. Diff Infection at 24 Months
Time frame: 24 months
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
10 secondary outcomes
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 90 Days
Time frame: 90 days
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 12 Months
Time frame: 12 months
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 24 Months
Time frame: 24 months
Quality of Life and Disease Activity Scores of Participants at Study Baseline
Time frame: Index visit
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 90 Days
Time frame: 90 Days
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 12 Months
Time frame: 12 months
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 24 Months
Time frame: 24 months
Rates of Health Care Utilization After Bezlotuxumab Infusion 90 Days
Time frame: 90 Days
Rates of Health Care Utilization After Bezlotuxumab Infusion 12 Months
Time frame: 12 months
Rates of Health Care Utilization After Bezlotuxumab Infusion 24 Months
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Diseases
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
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.
David Binion, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bezlotoxumab in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by David Binion, MD at 1 site 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 8 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 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Recurrent C. Diff Infection at 90 Days (time frame: 90 days). The study lists 3 primary outcomes in all. 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 5 Jun 2025.