Status:
COMPLETED
Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection
Lead Sponsor:
Dina Kao
Collaborating Sponsors:
University of Alberta
Conditions:
Enterocolitis
Recurrent Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 e...
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 re...
Eligibility Criteria
Inclusion
- 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
- 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 -
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03353506
Start Date
February 14 2018
End Date
October 10 2019
Last Update
February 20 2020
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G2X8