Actively Recruiting
Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms
Led by Seattle Children's Hospital · Updated on 2021-09-23
20
Participants Needed
1
Research Sites
497 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents between 7 and 21 years of age
- History of at least one infection due to extended-spectrum resistant Enterobacteriaceae defined as 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 will not qualify if you...
- History of malignancy or any immunocompromised state induced by disease or therapy
- Past or current use of systemic immunosuppressive agents; 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 stool culture)
- Allergy or hypersensitivity to omeprazole and polyethylene glycol
- Pregnancy
- Current frequent vomiting more than once per week
- 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 NG tube
- Presence of ventriculoperitoneal shunt or other intra-abdominal device, renal dialysis, ascites, or conditions increasing risk of peritonitis
- Bleeding disorders
- Current active ESC-R Enterobacteriaceae infection without completion of antibiotic treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
A
Amanda Adler
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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