Fecal Transplant for MDRO Decolonization

Multi-antibiotic Resistance Clinical Trial

Official title:

Fecal Microbiota Transplantation (FMT) for Intestinal Decolonization of Multidrug-resistant Opportunistic Pathogens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04181112
• Other study ID #: H19-00782 FMT.MDRO.RCT.1
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: November 2023

Study information

• Verified date: October 2021
• Source: University of British Columbia
• Contact: Amee Manges, MPH, PhD
• Phone: 604 707 2743
• Email: amee.manges[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Contact the study principal investigator for the study protocol.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multi-antibiotic Resistance

Intervention

Biological:
• Fecal Microbiota Transplantation (FMT)
FMT using retention enema

Locations

Country	Name	City	State
Canada	Providence Health Care - St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver Coastal Health - Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The elimination of the target multi-drug resistant organism (MDRO), using culture and molecular test-based screening of recipient stool, at both the 14 and 30 days post-FMT.		3 years
Secondary	Compare proportions, type and timing of adverse events post-FMT		3 years
Secondary	Proportions of recolonization over 180 days		3 years
Secondary	Timing of recolonization over 180 days		3 years