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Microbiota Transplantation
Fecal Microbiota Transplantation for Drug-Resistant Infections
Phase 1
Recruiting
Led By Danielle Zerr, MD, MPH
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Children and adolescents between 7 and 21 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-fmt; optional long-tern follow-up for 5 years post-fmt
Awards & highlights
Study Summary
This trial will test if FMT can help to get rid of a colon infection from a resistant bacterium in children.
Who is the study for?
This trial is for children and teens aged 7 to 21 who've had an infection caused by drug-resistant bacteria called ESC-R Enterobacteriaceae. They must be able to handle a nasogastric tube, not have allergies to certain medications, and attend all study visits. Pregnant individuals or those with specific gastrointestinal diseases, frequent vomiting, or on systemic immunosuppressants cannot join.Check my eligibility
What is being tested?
The trial tests fecal microbiota transplantation (FMT) in pediatric patients previously infected by resistant bacteria. It aims to see if FMT can remove these bacteria from the gut safely and effectively while checking how well kids tolerate this treatment.See study design
What are the potential side effects?
Potential side effects of FMT may include discomfort from the nasogastric tube placement, digestive upset like diarrhea or cramping, allergic reactions, and possibly infection risks due to introducing new gut bacteria.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had an infection caused by bacteria resistant to certain antibiotics.
Select...
I am between 7 and 21 years old.
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My guardian and I can attend all required study visits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post-fmt; optional long-tern follow-up for 5 years post-fmt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-fmt; optional long-tern follow-up for 5 years post-fmt
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fecal Microbiota Transplantation
Secondary outcome measures
Efficacy of FMT
Side effects data
From 2020 Phase 1 & 2 trial • 50 Patients • NCT0310684444%
Diarrhea
26%
Abdominal Pain
16%
Rectal Bleeding
12%
Constiption
10%
Fever
10%
Nausea
6%
Vomiting
6%
Fatigue
4%
Heart Burn
4%
Chills
4%
Migraine
4%
Yeast Infection
2%
Anemia
2%
IBD Flare
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota TransplantationExperimental Treatment1 Intervention
Subjects will receive 50mL of prepared stool fecal via nasogastric tube
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation
2016
Completed Phase 2
~350
Find a Location
Who is running the clinical trial?
Seattle Children's HospitalLead Sponsor
302 Previous Clinical Trials
5,216,704 Total Patients Enrolled
Danielle Zerr, MD, MPHPrincipal Investigator - Seattle Children's Hospital
Seattle Children's Hospital
Temple University School Of Medicine (Medical School)
University Of Wa School Of Medicine (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an infection caused by bacteria resistant to certain antibiotics.I have never had cancer before and my immune system is not compromised.You are allergic to omeprazole or polyethylene glycol.I have a bleeding disorder.I have active inflammation of the mouth or gut due to a transplant.I cannot have a tube placed through my nose into my stomach.I am willing and able to sign a consent form.I have a medical device inside me that could increase my risk of abdominal infection.I am between 7 and 21 years old.I am currently receiving radiation therapy to my abdomen.My guardian and I can attend all required study visits.I do not have an active ESC-R Enterobacteriaceae infection or have completed treatment for it.I haven't taken any drugs that weaken my immune system, except for creams, nasal sprays, or inhalers.I have an active inflammatory condition in my digestive system.I vomit more than once a week.
Research Study Groups:
This trial has the following groups:- Group 1: Fecal Microbiota Transplantation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the study open to participants over 40 years of age?
"This medical research is enrolling patients that are above the age of 7 and below 21 years old."
Answered by AI
Has the FDA sanctioned Fecal Microbiota Transplantation for use in treatments?
"The safety of Fecal Microbiota Transplantation is only provisionally supported by minimal clinical data, so it earned a score of 1."
Answered by AI
Might I be qualified to participate in this medical trial?
"This clinical trial is open to 20 minors aged between 7 and 21 who have contracted at least one infection stemming from the ESC-R Enterobacteriaceae family. These cases must be non-responsive to ceftriaxone, cefotaxime or ceftazidime treatments. The participants are expected to attend baseline and follow up visits with their parent/guardian present throughout these meetings."
Answered by AI
What is the highest participant threshold for this clinical experiment?
"Affirmative. According to the information provided by clinicaltrials.gov, recruitment for this investigation was initiated on February 17th 2017 and its details have been updated most recently on September 22nd 2021. The study is currently accepting 20 participants at a single site."
Answered by AI
Are there any vacancies available in this clinical trial?
"Data from clinicaltrials.gov reveals that this research is actively seeking out participants, with the initial posting occurring on February 17th 2017 and its most recent update being September 22nd 2021."
Answered by AI
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