Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms
22. september 2021 opdateret af: Danielle Zerr, Seattle Children's Hospital
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
20
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Amanda Adler
- Telefonnummer: 206-884-5086
- E-mail: amanda.adler@seattlechildrens.org
Studiesteder
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98105
- Rekruttering
- Seattle Children's Hospital
-
Kontakt:
- Danielle M Zerr, MD, MPH
- Telefonnummer: 206-987-2653
- E-mail: danielle.zerr@seattlechildrens.org
-
Kontakt:
- Amanda Adler, BA
- Telefonnummer: 206-884-5086
- E-mail: amanda.adler@seattlechildrens.org
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
7 år til 21 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
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Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Fecal Microbiota Transplantation
Subjects will receive 50mL of prepared stool fecal via nasogastric tube
|
Fecal Microbiota Transplantation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety and Tolerability of FMT as measured by Incidence, severity, and relatedness of solicited, unsolicited, and serious adverse events
Tidsramme: 12 months post-FMT; optional long-tern follow-up for 5 years post-FMT
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Efficacy of FMT
Tidsramme: 2 days, 2 weeks, 4 weeks, 8 weeks, 6 months, 12 months post-FMT
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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
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2 days, 2 weeks, 4 weeks, 8 weeks, 6 months, 12 months post-FMT
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Danielle Zerr, MD, MPH, Seattle Children's Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
17. februar 2017
Primær færdiggørelse (Forventet)
1. september 2023
Studieafslutning (Forventet)
1. september 2026
Datoer for studieregistrering
Først indsendt
4. september 2015
Først indsendt, der opfyldte QC-kriterier
4. september 2015
Først opslået (Skøn)
7. september 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. september 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 15587
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ja
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Ingen
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