Oral Capsule Faecal Microbiota Transplantation for CPE Decolonization

NCT ID: NCT04746222

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2023-07-31

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 Enterobacteriaceae (CPE) intestinal decolonisation compared with placebo. Primary outcome is the proportion of patients successfully decolonised of CPE intestinal carriage at 12 weeks after FMT treatment compared with placebo.

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment

Single dose of 30 oral capsules containing FMT from a stool bank

Group Type: EXPERIMENTAL

Oral capsule faecal microbiota transplantation

Intervention Type: BIOLOGICAL

Single dose of 30 oral capsules containing healthy donor stool from a stool bank

Placebo

Single dose of 30 oral placebo capsules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Single dose of 30 oral placebo capsules

Interventions

Oral capsule faecal microbiota transplantation

Single dose of 30 oral capsules containing healthy donor stool from a stool bank

Intervention Type: BIOLOGICAL

Placebo

Single dose of 30 oral placebo capsules

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Singapore Clinical Research Institute

OTHER

Sponsor Role: collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oon Tek Ng, MBBS

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Central Contacts

Oon Tek Ng, MBBS

Role: CONTACT

Oon_Tek_NG@ttsh.com.sg

+65 6357 7318

Kalisvar Marimuthu, MBBS

Role: CONTACT

kalisvar_marimuthu@ttsh.com.sg

Other Identifiers

CSAINV18nov-006

Identifier Type: -

Identifier Source: org_study_id