Fecal Microbiota Transplant for Drug-Resistant Infections
Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms
Recruiting
Phase 1Interventional Study
Infection Resistant to Drugs
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
7 – 21
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
20 (estimated)
Sponsor
Seattle Children's Hospital · Other
Who this trial is looking for
This trial is looking for children and young adults aged 7 to 21 years who have had an infection caused by specific drug-resistant bacteria. Participants will receive a treatment called fecal microbiota transplantation to see if it helps eliminate these bacteria from their intestines.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 7 and 21 years old.
I have had at least one infection caused by drug-resistant bacteria.
I can attend study visits with my parent or guardian.
I am willing to give my consent or assent for participation.
You may not be able to join if
I have a history of cancer or am immunocompromised.
I have used immunosuppressive medications in the past or currently.
I do not carry the specific drug-resistant bacteria.
I am allergic to omeprazole or polyethylene glycol.
I am pregnant.
I vomit frequently more than once a week.
I have active inflammatory bowel disease or other serious gastrointestinal issues.
I currently have an active infection and haven't finished my antibiotic treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 effica…
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.
Trial Locations
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Eligibility Criteria
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 …
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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