Fecal Transplant for MDR Pathogen Decolonization

Multi-antibiotic Resistance Clinical Trial

Official title:

A Prospective, Case-series Study of Fecal Microbiota Transplantation for the Selective Intestinal Decolonization of Multidrug-resistant, Pathogenic Enterobacteriaceae

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02906774
• Other study ID #: H15-01944
• Status: Terminated
• Start date: April 2016
• Est. completion date: November 2019

Study information

• Verified date: November 2019
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a proof-of-principle research study 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 by 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: Terminated
• Enrollment: 3
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Renal transplant patient inclusion criteria:

• 18 years or older

• Able to provide informed consent

• Positive for one of the target MDR organisms 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)

• Colonized with Clostridium difficile

• Presence of colostomy or ileostomy

• Has an active intestinal infection

• Fever > 38.0 or 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, ESBL 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)
Fecal microbiota transplantation after antibiotic pretreatment

Locations

Country	Name	City	State
Canada	University of British Columbia	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 primary outcome of the study will be the proportion of successfully decolonized patients out of all study patients evaluated, defined as the sustained elimination of a MDR target organism over a minimum of = 2 study visits.		6 months
Secondary	Determine the number of patients with treatment-related adverse events, as defined by the study adverse event questionnaire (including the Common Terminology Criteria for Adverse Events (v4.0)).		6 months
Secondary	Estimate the proportion of patients who become re-colonized following FMT.		6 months