- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03353506
Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection
A Prospective Double Blind Randomized Pilot Study Comparing the Efficacy of Lyophilized Fecal Microbiota Transplantation (FMT) to Lyophilized Sterile Fecal Filtrate in the Management of Recurrent Clostridium Difficile Infection (CDI)
Fecal microbiota transplantation (FMT) for the treatment of recurrent Clostridium difficile infection (RCDI) has traditionally been offered as fecal slurry administered by enema, nasogastric tube or endoscopy. Frozen oral capsules have also shown efficacy. The potential advantage of lyophilized FMT is the relative ease of manufacturing and storage compared with fecal slurry.
Sterile fecal filtrate has previously been shown to prevent Clostridium difficile infection (CDI) recurrence, suggesting that live bacteria may not be needed. This study will compare lyophilized sterile fecal filtrate (LSFF) with lyophilized FMT (LFMT) in the treatment of recurrent Clostridium difficile infection (RCDI).
Study Overview
Status
Intervention / Treatment
Detailed Description
This prospective double blind randomized pilot study will enroll 40 subjects with recurrent Clostridium difficile infection in a 1:1 ratio to receive either LSFF or LFMT by capsules.
Subjects will receive 15 capsules at week 0 and be assessed at Weeks 1, 4, 12 and 24. If treatment fails, subjects will be given open label LFMT from the same donor. If treatment fails again, another FMT will be offered and the form and route of FMT delivery will be at the discretion of the treating physician.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G2X8
- University of Alberta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- at least 3 episodes of recurrent CDI, with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile toxin, each occurring within 3 months of each other.
- CDI under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
- Ability to provide informed consent.
- Females and males must agree to use effective contraception for the duration of the study as applicable
Exclusion Criteria:
- Complicated CDI defined as WBC >35, significant abdominal pain and distention, evidence of toxin megacolon or pseudomembraneous colitis, hypotension defined as systolic blood pressure <90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring admission to intensive care.
- Chronic diarrheal illness such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission of 3 months prior to enrollment.
- Taking or planning to take an investigational drug within 3 months of enrollment.
- Immunosuppression
- Chemotherapy or radiation therapy
- oropharyngeal or significant esophageal dysphagia
- Ileus or small bowel obstruction
- Subtotal colectomy
- Pregnancy or planning to become pregnant within 3 months of enrollment
- Breastfeeding or planning to breastfeed during the trial
- Active infection requiring antibiotic therapy.
- Life expectancy <6 months -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: LFMT
Lyophilized fecal microbiota transplant capsules
|
Lyophilized fecal microbiota transplant
|
Experimental: LSFF
Lyophilized sterile fecal filtrate capsules
|
Lyophilized sterile fecal filtrate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resolution of RCDI
Time Frame: 8 weeks
|
Proportion of subjects without RCDI
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resolution of RCDI
Time Frame: 24 weeks
|
Proportion of subjects with sustained cure
|
24 weeks
|
Serious Adverse Events
Time Frame: 8 weeks
|
Mortality directly attributable to CDI or treatment
|
8 weeks
|
Serious Adverse Events
Time Frame: 8 weeks
|
Infection directly attributable to treatment
|
8 weeks
|
Minor Adverse Events
Time Frame: 1 week
|
nausea
|
1 week
|
Minor Adverse Events
Time Frame: 1 week
|
vomiting
|
1 week
|
Minor Adverse Events
Time Frame: 1 week
|
abdominal pain
|
1 week
|
Difficulty in swallowing capsules
Time Frame: 1 week
|
Reported by subjects as ranging between none, moderate or severe
|
1 week
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00076309
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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