Clostridium Difficile InfectionPhase 1NCT02981316
Treatment of Recurrent Clostridium Difficile Infection With RBX7455
A Phase 1 study testing RBX7455 in people with Clostridium Difficile Infection, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the efficacy and safety of RBX7455 for the treatment of recurrent CDI in subjects who have had at least one recurrence after a primary episode (i.e., at least two episodes) and have completed at least two rounds of standard-of-care oral antibiotic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- RBX7455
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 22 Jul 2020
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old.
- Medical record documentation of recurrent CDI, defined as at least one recurrence after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy. Study subjects will have their diarrhea resolved, i.e., would be having less than 3 watery bowel movements at the time of study enrollment for 48 hours or more.
- A positive stool test for the presence of C. difficile within 30 days prior to enrollment and standard C. difficile treatment.
- Willing and able to swallow capsules.
- Agrees to abstain from non-dietary probiotics for the duration of the study.
- Agrees to abstain from vancomycin, metronidazole, fidaxomicin, rifaximin, nitazoxanide and IVIG for the duration of the study unless prescribed to treat recurrent CDI.
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- Agrees to stop proton pump inhibitors or H2 blocker medications.
- Agrees to practice a form of effective contraception during study participation.
- Has a negative urine pregnancy test at the time of enrollment (females of child-bearing potential only).
- Willing and able to provide informed consent and HIPAA authorization.
- Willing and able to complete the required Subject Diary.
- Willing and able to meet all study requirements, including attending all assessment visits and phone calls.
Who cannot join
- A known history of continued CDI diarrhea, despite being on a course of antibiotics prescribed for CDI treatment.
- Requires continuous antibiotic therapy for a condition other than CDI.
- Previous fecal transplant.
- Previous treatment with RBX2660.
- Diagnosis of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
- Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
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- History of chronic diarrhea.
- History of celiac disease.
- Disease symptoms caused by a confirmed intestinal pathogen other than C. difficile.
- Unable to stop proton pump inhibitors or H2 blocker medications.
- Colostomy.
- Intra-abdominal surgery within the last 60 days.
- Evidence of active, severe colitis.
- History of short gut syndrome.
- Requires the regular use of medications to manage bowel hypermotility.
- Planned therapy in the next 3 months that may cause diarrhea (e.g., chemotherapy).
- Planned surgery requiring perioperative antibiotics within 3 months of study enrollment.
- Life expectancy of < 6 months.
- Compromised immune system (e.g., HIV infection; AIDS-defining diagnosis or CD4 <200/mm3; inherited/primary immune disorders; immunodeficient or immunosuppressed due to a medical condition or medication; current or recent (< 90 days) treatment with chemotherapy; or current or recent (< 90 days) treatment with immunosuppressant medications.
- Taking systemic steroids (≥ 20 mg a day or prednisone-equivalent) or is expected to be on steroids after enrollment through 8 weeks after completing the assigned study treatment.
- An absolute neutrophil count of <1000 cells/µL.
- Known or suspected current (< 90 days) illicit drug use. Note: marijuana use is allowed.
- Pregnant, breastfeeding, or intends to become pregnant during study participation.
- Participating in a clinical trial of another investigational product (drug, device or other) and has not completed the required follow-up period.
- Subject, in the opinion of the investigator, for whatever reason, should be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Treatment of Recurrent Clostridium Difficile Infection With RBX7455: A Dose-ranging, Prospective, Single Center, Open Label Phase I Trial
The purpose of this study is to demonstrate the efficacy and safety of RBX7455 for the treatment of recurrent CDI in subjects who have had at least one recurrence after a primary episode (i.e., at least two episodes) and have completed at least two rounds of standard-of-care oral antibiotic therapy.
- Conditions
- Clostridium Difficile Infection
- Being tested
- RBX7455
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBX7455Biological
Microbiota capsule(s) given twice daily in the morning, and in the evening.
| Study group | Role | What they receive |
|---|---|---|
| RBX7455 Group A | Active comparator | 4 days of 4 capsules twice daily RBX7455 for 10 subjects. Receives: Biological: RBX7455 |
| RBX7455 Group B | Active comparator | 2 days of 4 capsules twice daily RBX7455 for 10 subjects. Receives: Biological: RBX7455 |
| RBX7455 Group C | Active comparator | 2 days of 2 capsules twice daily RBX7455 for 10 subjects. Receives: Biological: RBX7455 |
| RBX7455 Group D | Active comparator | 2 days of 1 capsule twice daily RBX7455 for 10 subjects. Receives: Biological: RBX7455 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrence of Clostridium Difficile Infection (CDI)
Measured: approximately 8 weeks
Number of patients experiencing adverse events
Measured: approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion22 Jul 2020
- Study completion22 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Rebiotix Inc.
- Responsible party
- Principal investigator, Sahil Khanna, Mayo Clinic
- Investigators
- Sahil Khanna, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981316
- Sponsor's protocol ID
- 15-008828
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2016
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khanna S, Pardi DS, Jones C, Shannon WD, Gonzalez C, Blount K. RBX7455, a Non-frozen, Orally Administered Investigational Live Biotherapeutic, Is Safe, Effective, and Shifts Patients' Microbiomes in a Phase 1 Study for Recurrent Clostridioides difficile Infections. Clin Infect Dis. 2021 Oct 5;73(7):e1613-e1620. doi: 10.1093/cid/ciaa1430.
PubMed 32966574
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Recurrent Clostridium Difficile Infection With RBX7455: A Dose-ranging, Prospective, Single Center, Open Label Phase I Trial
- ClinicalTrials.gov ID
- NCT02981316
- Acronym / sponsor ID
- 15-008828
- Conditions
- Clostridium Difficile Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Rebiotix Inc.
- Study start
- Nov 2016
- Primary completion
- 22 Jul 2020 (actual)
- Study completion
- 22 Jul 2020 (actual)
- First posted
- 5 Dec 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 purpose of this study is to demonstrate the efficacy and safety of RBX7455 for the treatment of recurrent CDI in subjects who have had at least one recurrence after a primary episode (i.e., at least two episodes) and have completed at least two rounds of standard-of-care oral antibiotic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RBX7455 Group A | Active comparator | Biological: RBX74554 days of 4 capsules twice daily RBX7455 for 10 subjects. |
| RBX7455 Group B | Active comparator | Biological: RBX74552 days of 4 capsules twice daily RBX7455 for 10 subjects. |
| RBX7455 Group C | Active comparator | Biological: RBX74552 days of 2 capsules twice daily RBX7455 for 10 subjects. |
| RBX7455 Group D | Active comparator | Biological: RBX74552 days of 1 capsule twice daily RBX7455 for 10 subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ≥ 18 years old.
- Medical record documentation of recurrent CDI, defined as at least one recurrence after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy. Study subjects will have their diarrhea resolved, i.e., would be having less than 3 watery bowel movements at the time of study enrollment for 48 hours or more.
- A positive stool test for the presence of C. difficile within 30 days prior to enrollment and standard C. difficile treatment.
- Willing and able to swallow capsules.
- Agrees to abstain from non-dietary probiotics for the duration of the study.
Key exclusion criteria (25 listed)
- A known history of continued CDI diarrhea, despite being on a course of antibiotics prescribed for CDI treatment.
- Requires continuous antibiotic therapy for a condition other than CDI.
- Previous fecal transplant.
- Previous treatment with RBX2660.
- Diagnosis of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
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 |
|---|---|---|
| RBX7455Microbiota capsule(s) given twice daily in the morning, and in the evening. | Biological | RBX7455 Group A, RBX7455 Group B, RBX7455 Group C, RBX7455 Group D |
Primary outcome
Time to recurrence of Clostridium Difficile Infection (CDI)
Time frame: approximately 8 weeks
Number of patients experiencing adverse events
Time frame: approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Derived from this study: PubMed 32966574Khanna S, Pardi DS, Jones C, Shannon WD, Gonzalez C, Blount K. RBX7455, a Non-frozen, Orally Administered Investigational Live Biotherapeutic, Is Safe, Effective, and Shifts Patients' Microbiomes in a Phase 1 Study for Recurrent Clostridioides difficile Infections. Clin Infect Dis. 2021 Oct 5;73(7):e1613-e1620. doi: 10.1093/cid/ciaa1430.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sahil Khanna principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RBX7455 in people with Clostridium Difficile Infection, run by Mayo Clinic 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 12 inclusion and 25 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: finished, as of the sponsor's last update on 8 Dec 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 to recurrence of Clostridium Difficile Infection (CDI) (time frame: approximately 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02981316, which also lists 1 linked publication.
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 8 Dec 2020.