Status:
UNKNOWN
Oral Capsule Faecal Microbiota Transplantation for CPE Decolonization
Lead Sponsor:
Tan Tock Seng Hospital
Collaborating Sponsors:
Singapore Clinical Research Institute
Conditions:
Carbapenem-Resistant Enterobacteriaceae Infection
Eligibility:
All Genders
21+ years
Phase:
PHASE2
PHASE3
Brief Summary
Double-blinded, randomised controlled trial to evaluate the clinical efficacy of a single dose of oral capsule-administered faecal microbiota transplantation (FMT) for carbapenemase-producing Enteroba...
Eligibility Criteria
Inclusion
- Admitted as inpatient at the study site at the time of screening.
- Aged ≥21 years at the time of screening.
- Sufficiently ambulant to return for outpatient clinic study visit.
- Detection of CPE (result reported by clinical microbiology laboratory).
- Ability to provide informed consent.
- Females of childbearing potential who are sexually active with a non-sterilised male partner must agree to use at least one method of effective contraception for the duration of the trial.
- Colonisation of the gastrointestinal tract with CPE, confirmed by at least one positive rectal swab taken ≤7 days before randomisation (direct PCR testing using Xpert Carba-R, performed by study team independent of the hospital screening protocol).
- Ability to swallow "safety test" capsule (one test capsule given during pre-randomisation evaluation).
- Antibiotics ceased for at least 48 hours before pre-randomisation evaluation.
- Negative urine pregnancy test for pre-menopausal women taken ≤7 days before randomisation
Exclusion
- Presence of acute diarrhoeal illness (e.g. gastroenteritis, C. difficile colitis) or chronic diarrhoeal illness (e.g. irritable bowel syndrome or inflammatory bowel disease, unless they are in remission for at least 3 months prior to enrolment).
- Current use or planned use of an investigational drug within 3 months of enrolment.
- Presence of significant immunosuppression, including but not limited to: use of monoclonal antibody, use of prolonged steroids equivalent to prednisolone dose of ≥20mg/day for ≥28 days, solid organ transplantation, bone marrow transplantation, HIV infection with CD4 count of ≤200, bone marrow transplant, ongoing chemotherapy or radiation therapy, and congenital immunodeficiency.
- Oropharyngeal dysphagia, significant oesophageal dysphagia, or other inability to swallow.
- History of surgery altering gastrointestinal anatomy (e.g. colostomy, colectomy).
- Ileus or small bowel obstruction.
- Risk of aspiration.
- History of gastroparesis.
- Severe food allergy (anaphylaxis or anaphylactoid reaction).
- Adverse event attributable to previous FMT.
- Those who are pregnant or plan to be pregnant within 3 months of enrolment.
- Those who are breastfeeding or plan to breastfeed during the trial.
- Life expectancy \<3 months.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04746222
Start Date
July 1 2021
End Date
July 1 2023
Last Update
February 9 2021
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