Fecal Transplant for MDRO Decolonization

University of British Columbia

Status

Unknown

Conditions

Multi-antibiotic Resistance

Treatments

Biological: Fecal Microbiota Transplantation (FMT)

Study type

Interventional

Funder types

Other

Identifiers

NCT04181112

H19-00782 FMT.MDRO.RCT.1

Details and patient eligibility

About

This is a trial designed to determine whether fecal microbiota transplantation (FMT) can eliminate highly drug-resistant bacteria from the intestinal tract of renal transplant patients. The primary goal of this study is to test whether oral gut decontamination followed by FMT using enema delivery will result in decolonization of the intestinal tract of renal transplant patients shortly after solid organ transplantation, thereby preventing difficult to treat post-transplant infections.

Full description

Contact the study principal investigator for the study protocol.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Renal transplant patient inclusion criteria:

18 years or older
Able to provide informed consent
Positive for one of the target MDRO by rectal or stool culture tests

FMT stool donor inclusion criteria:

Able to provide informed consent
Able to complete donor screening
Able to adhere to FMT stool collection and testing procedures

Renal transplant patient exclusion criteria:

Still in hospital at week 7 following organ transplantation
Pregnant or planning to become pregnant
Breastfeeding
Participating in another interventional or investigational study
Neutropenic (ANC < 0.5)
Presence of colostomy or ileostomy
Has an active intestinal infection
Fever > 38.0 or white blood count (WBC) count > 15,000
Are taking a non-dietary probiotic supplement
Require or are expected to require systemic antimicrobial therapy other than Pneumocystis prophylaxis or cytomegalovirus (CMV) therapy during the study period
Has a severe underlying disease with anticipated survival less than 6 months
Are unable to tolerate FMT or enema for any reason, or where their physician believes for any reason that FMT might pose a health risk to the subject
Subjects who report a history of anaphylactoid food allergy will not be excluded but these allergies will be noted and donors will be required to avoid ingestion of these foods for at least three days prior to donation

FMT stool donor exclusion criteria:

Presence of any of the following by stool examination: vancomycin-resistant Enterococci (VRE), Salmonella, Shigella, shiga toxin-producing E. coli, Yersinia, Campylobacter, extended spectrum beta-lactamase (ESBL) producing organisms or carbapenemase-producing Enterobacteriaceae (CRE), pathogenic ova or parasites, C. difficile toxin B (by PCR), or rotavirus, adenovirus and norovirus
History of any type of active cancer aside from melanoma
Risk factors for acquisition of HIV, syphilis, Hepatitis B, Hepatitis C, prion or any neurological disease as determined by the donor questionnaire
History of gastrointestinal comorbidities, e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation or diarrhea, or colostomy or ileostomy
Receipt of blood transfusion from a country other than Canada in the preceding 6 months
Antibiotic use or any systemic immunosuppressive agents in the 3 months prior to stool donation
Receipt of any live vaccine within 3 months prior to stool donation
Any current or previous medical or psychosocial condition or behaviors which in the opinion of the investigator may pose risk to the recipients or the donor