Infection Resistant to DrugsPhase 1NCT02543866
Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms
A Phase 1 study testing Fecal Microbiota Transplantation in people with Infection Resistant to Drugs, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Infection Resistant to Drugs
- What is being tested?
- Fecal Microbiota Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2017to Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Danielle M Zerr, MD, MPH, 206-987-2653, danielle.zerr@seattlechildrens.org
Amanda Adler, BA, 206-884-5086, amanda.adler@seattlechildrens.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Infection Resistant to Drugs
- Being tested
- Fecal Microbiota Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationBiological
Fecal Microbiota Transplantation
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation | Experimental | Subjects will receive 50mL of prepared stool fecal via nasogastric tube Receives: Biological: Fecal Microbiota Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months post-FMT; optional long-tern follow-up for 5 years post-FMT
Secondary outcomes (1)
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
Measured: 2 days, 2 weeks, 4 weeks, 8 weeks, 6 months, 12 months post-FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study start17 Feb 2017
- Primary completionSep 2023 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection Resistant to DrugsStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Zerr, Seattle Children's Hospital
- Investigators
- Danielle Zerr, MD, MPH, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543866
- Sponsor's protocol ID
- 15587
- Status last verified
- Sep 2021
- First submitted
- 4 Sep 2015
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation as a Strategy to Eradicate Intestinal Carriage of Resistant Organisms
- ClinicalTrials.gov ID
- NCT02543866
- Acronym / sponsor ID
- 15587
- Conditions
- Infection Resistant to Drugs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplantation | Experimental | Biological: Fecal Microbiota TransplantationSubjects will receive 50mL of prepared stool fecal via nasogastric tube |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota TransplantationFecal Microbiota Transplantation | Biological | Fecal Microbiota Transplantation |
Primary outcome
Safety and Tolerability of FMT as measured by Incidence, severity, and relatedness of solicited, unsolicited, and serious adverse events
Time frame: 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
1 secondary outcome
Efficacy of FMT
Time frame: 2 days, 2 weeks, 4 weeks, 8 weeks, 6 months, 12 months post-FMT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Zerr, MD, MPH principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fecal Microbiota Transplantation in people with Infection Resistant to Drugs, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda Adler (206-884-5086, amanda.adler@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of FMT as measured by Incidence, severity, and relatedness of solicited, unsolicited, and serious adverse events (time frame: 12 months post-FMT; optional long-tern follow-up for 5 years post-FMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.