Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms

Fecal Microbiota Transplantation as a Strategy to Eradicate Intestinal Carriage of Resistant Organisms

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.

Study Overview

• Status: Recruiting
• Conditions: Infection Resistant to Drugs
• Intervention / Treatment: Biological: Fecal Microbiota Transplantation

Detailed Description

This is a prospective pilot study of fecal microbiota transplantation in pediatric patients with a history of ESC-R Enterobacteriaceae. Subjects who meet inclusion/exclusion criteria and provide written, informed consent will undergo screening studies and provide a pre-FMT stool sample to confirm intestinal carriage of ESC-R Enterobacteriaceae. The FMT will be administered by nasogastric tube in the outpatient setting by trained personnel. The subjects will be monitored for potential adverse events, recurrence of MDRO infections, infections that may be related to FMT, and worsening of existing comorbidities or development of new comorbidities for the 12 months post-FMT with the option of participating in long-term follow-up for up to 5 years post-FMT. Patients will provide stool samples 2 days, 2 weeks, 4 weeks, 8 weeks, 6 months, and 12 months post-FMT. These samples will be testing for ESC-R Enterobacteriaceae.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Amanda Adler; Phone Number: 206-884-5086; Email: amanda.adler@seattlechildrens.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital
      • Contact: Danielle M Zerr, MD, MPH; Phone Number: 206-987-2653; Email: danielle.zerr@seattlechildrens.org
      • Contact: Amanda Adler, BA; Phone Number: 206-884-5086; Email: amanda.adler@seattlechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Children and adolescents between 7 and 21 years of age.
2. 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.
3. Parent/guardian and participant must be able to attend baseline and follow-up study visits.
4. Subject must be willing and able to provide written informed consent or assent (as appropriate by age).

Exclusion Criteria:

1. 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.
2. 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.
3. Lack of intestinal carriage of ESC-R Enterobacteriaceae (negative selective stool culture for ESC-R Enterobacteriaceae).
4. Allergy or hypersensitivity to omeprazole and polyethylene glycol.
5. Pregnancy.
6. Current history of frequent (>1 per week) vomiting.
7. Active inflammatory gastrointestinal disease, such as inflammatory bowel disease
8. Active mucositis or acute graft versus host disease of the gastrointestinal tract
9. Concurrent abdominal radiation therapy.
10. Inability to tolerate nasogastric tube placement or contraindication to having an NG tube placed.
11. 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.
12. Bleeding diatheses

13. Patients with current active ESC-R Enterobacteriaceae infection who have not yet completed antibiotic treatment will be excluded until their treatment is completed

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fecal Microbiota Transplantation; Subjects will receive 50mL of prepared stool fecal via nasogastric tube	Biological: Fecal Microbiota Transplantation; Fecal Microbiota Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of FMT	Proportion of subjects free from ESC-R intestinal colonization and recurrent ESC-R infections 2 days, 2 weeks, 4 weeks, 8 weeks, 6 months, and 12 months post-FMT	2 days, 2 weeks, 4 weeks, 8 weeks, 6 months, 12 months post-FMT

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Investigators: Principal Investigator: Danielle Zerr, MD, MPH, Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2017
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2026

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 15587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No