Using fecal microbiota transplantation to treat drug-resistant infections in children
Fecal Microbiota Transplantation as a Strategy to Eradicate Intestinal Carriage of Resistant Organisms
This study is testing if a treatment using healthy stool can help children aged 7 to 21 who have tough-to-treat infections get better by clearing harmful bacteria from their intestines.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 7 Years to 21 Years |
| Sex | All |
| Sponsor | Seattle Children's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT02543866 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the use of fecal microbiota transplantation (FMT) to eliminate intestinal colonization of extended-spectrum resistant Enterobacteriaceae in pediatric patients. Participants aged 7 to 21 with a history of such infections will undergo FMT administered via nasogastric tube in an outpatient setting. The study will assess the feasibility, safety, tolerability, and potential efficacy of FMT, with participants monitored for adverse events and infection recurrence for up to 12 months post-procedure. Stool samples will be collected at various intervals to track the presence of resistant organisms.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 7 to 21 with a documented history of infections caused by extended-spectrum resistant Enterobacteriaceae.
Not a fit: Patients with malignancies, immunocompromised states, or those who do not carry ESC-R Enterobacteriaceae will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for children suffering from infections resistant to conventional antibiotics.
How similar studies have performed: While fecal microbiota transplantation has shown promise in other contexts, this specific application for drug-resistant infections in pediatric patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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
\-
Where this trial is running
Seattle, Washington
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Danielle Zerr, MD, MPH — Seattle Children's Hospital
- Study coordinator: Amanda Adler
- Email: amanda.adler@seattlechildrens.org
- Phone: 206-884-5086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.