Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms

NCT02543866 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 15587
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol will evaluate fecal microbiota transplantation (FMT) as a strategy to eradicate intestinal colonization of extended-spectrum resistant (ESC-R) Enterobacteriaceae in pediatric patients. FMT will be performed on subjects with a history of at least one infection due to ESC-R Enterobacteriaceae. This protocol aims to determine the feasibility, safety, tolerability, and potential efficacy of FMT in pediatric patients with a history of ESC-R Enterobacteriaceae.

Conditions

Infection Resistant to Drugs

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of FMT as measured by Incidence, severity, and relatedness of solicited, unsolicited, and serious adverse events

  Incidence, severity, and relatedness of solicited, unsolicited, and serious adverse events

  12 months post-FMT; optional long-tern follow-up for 5 years post-FMT

Secondary Outcomes (1)

• Efficacy of FMT

  2 days, 2 weeks, 4 weeks, 8 weeks, 6 months, 12 months post-FMT

Study Arms (1)

Fecal Microbiota Transplantation

EXPERIMENTAL

Subjects will receive 50mL of prepared stool fecal via nasogastric tube

Biological: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation BIOLOGICAL

Fecal Microbiota Transplantation

Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents between 7 and 21 years of age.
• A history at least one infection due to ESC-R Enterobacteriaceae. ESC-R isolates will be defined as those non-susceptible to ceftriaxone, cefotaxime, or ceftazidime.
• Parent/guardian and participant must be able to attend baseline and follow-up study visits.
• Subject must be willing and able to provide written informed consent or assent (as appropriate by age).

You may not qualify if:

• Patients with any history of malignancy or any immunocompromised state (e.g. absolute neutrophil count outside the normal range) induced by disease or therapy will be excluded.
• Patients with past or current use of systemic immunosuppressive agents will be excluded. Receipt of non-systemic agents such as inhaled, nasal, or topical steroids or immune-modulating agents are allowed.
• Lack of intestinal carriage of ESC-R Enterobacteriaceae (negative selective stool culture for ESC-R Enterobacteriaceae).
• Allergy or hypersensitivity to omeprazole and polyethylene glycol.
• Pregnancy.
• Current history of frequent (\>1 per week) vomiting.
• Active inflammatory gastrointestinal disease, such as inflammatory bowel disease
• Active mucositis or acute graft versus host disease of the gastrointestinal tract
• Concurrent abdominal radiation therapy.
• Inability to tolerate nasogastric tube placement or contraindication to having an NG tube placed.
• Presence of a ventriculoperitoneal shunt or other intrabdominal device, receipt of renal dialysis, presence of ascites, or other conditions/devices that would increase the risk of peritonitis.
• Bleeding diatheses
• Patients with current active ESC-R Enterobacteriaceae infection who have not yet completed antibiotic treatment will be excluded until their treatment is completed

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Danielle Zerr, MD, MPH

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Adler

CONTACT

206-884-5086; amanda.adler@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 7, 2015
• Study Start: February 17, 2017
• Primary Completion: September 1, 2023
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)