Trial record 1 of 1 for:
NCT02299570
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD2)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02299570 |
|
Recruitment Status :
Completed
First Posted : November 24, 2014
Results First Posted : July 27, 2018
Last Update Posted : January 15, 2021
|
Sponsor:
Rebiotix Inc.
Information provided by (Responsible Party):
Rebiotix Inc.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Enterocolitis Clostridium Difficile Recurrent | Biological: RBX2660 (microbiota suspension) Other: Placebo | Phase 2 |
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. The primary assessments for this study are (i) efficacy of RBX2660 compared to placebo at 8 weeks and (ii) safety via assessment of adverse events. Study visits are at 1-, 4- and 8-weeks after treatment with additional follow-up at 3, 6 12 and 24 months post treatment. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2B Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study Demonstrating the Efficacy and Safety of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection |
| Actual Study Start Date : | December 2014 |
| Actual Primary Completion Date : | January 2016 |
| Actual Study Completion Date : | January 2018 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Group A
Two enemas of RBX2660 (microbiota suspension) administered 7 days apart
|
Biological: RBX2660 (microbiota suspension)
A suspension of intestinal microbes |
|
Placebo Comparator: Group B
Two enemas of placebo administered 7 days apart
|
Other: Placebo
A suspension of saline and cryoprotectant |
|
Active Comparator: Group C
1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart
|
Biological: RBX2660 (microbiota suspension)
A suspension of intestinal microbes Other: Placebo A suspension of saline and cryoprotectant |
Primary Outcome Measures :
- Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) [ Time Frame: 8 weeks after last assigned study treatment ]The primary endpoint is to evaluate treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema, of Group A (two enemas of RBX2660) vs. Group B (two enemas of placebo).
Secondary Outcome Measures :
- Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT) [ Time Frame: 8-weeks ]Treatment Success was defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema
- Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT) [ Time Frame: 8-weeks ]Treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema.
- SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) [ Time Frame: 8-week ]The validated SF-36 scale was used to identify changes to quality of life (QoL) following study treatment. Each component is analyzed on a norm-based scoring (0-100) with a higher score representing an improvement in QoL.
- Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) [ Time Frame: 8-weeks ]Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
- Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) [ Time Frame: 8-weeks ]Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
- Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) [ Time Frame: 8-weeks ]Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ≥ 18 years
- Medical record documentation of recurrent CDI either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization.
- Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics.
- A positive stool test for the presence of C. difficile within 60 days prior to enrollment.
Exclusion Criteria:
- A known history of continued C. difficile diarrhea while taking on a course of antibiotics prescribed for CDI treatment.
- Requires antibiotic therapy for a condition other than recurrent CDI.
- Previous fecal transplant prior to study enrollment.
- History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
- History of irritable bowel syndrome (IBS).
- History of chronic diarrhea.
- History of celiac disease.
- Colostomy.
- Planned surgery requiring perioperative antibiotics within 6 months of study enrollment.
- Life expectancy of < 12 months.
- Compromised immune system.
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): NCT02299570
Locations
Show 21 study locations
Sponsors and Collaborators
Rebiotix Inc.
Investigators
| Study Chair: | Teena Chopra, MD MPH | Wayne State University |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rebiotix Inc. |
| ClinicalTrials.gov Identifier: | NCT02299570 |
| Other Study ID Numbers: |
2014-01 |
| First Posted: | November 24, 2014 Key Record Dates |
| Results First Posted: | July 27, 2018 |
| Last Update Posted: | January 15, 2021 |
| Last Verified: | December 2020 |
Keywords provided by Rebiotix Inc.:
|
Clostridium difficile C diff CDI CDAD Fecal transplant Fecal Microbiota Transplant |
Diarrhea FMT Microbiota restoration therapy Microbiota suspension Fecal bacteriotherapy C diff diarrhea |
Additional relevant MeSH terms:
|
Clostridium Infections Enterocolitis Recurrence Infections Disease Attributes Pathologic Processes Gram-Positive Bacterial Infections |
Bacterial Infections Bacterial Infections and Mycoses Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |