- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02108821
Fecal Microbiota Transplantation in Pediatric Patients (FMT)
A Study of Fecal Microbiota Transplantation in Pediatric Patients With Relapsed Inflammatory Bowel Disease.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
STUDY SUBJECT INCLUSION CRITERIA:
Current IBD patients who have:
- UC patients with a flare due to failure of current therapy and have to undergo esophagogastroduodenoscopy (EGD) and colonoscopy for restaging the disease and escalation of therapy.
- CD patients with ileo colonic or colonic disease who require an EGD and colonoscopy for disease assessment due to a flare or poor control.
- The ability to safely undergo colonoscopy (physical status classification used by the American Society of Anesthesiologists).
- PUCAI score less than sixty five.
- PCDAI score less than forty.
STUDY SUBJECTS EXCLUSION CRITERIA:
- Patients with Crohn's disease: complications like an abscess, phlegmon, stricture, small bowel obstruction, perforation, internal or external fistulization or infection as causes for flare up before being deemed eligible for recruitment to the study. We will check for these complications if a recent study has not been done.
- Severe immunosuppression: Biologicals with concomitant steroids (>30 mg/day).
- Central Line.
- Pressor or ventilatory support.
- On antibiotics.
- Patients with Crohn's disease found to have complications like an abscess, phlegmon, stricture, small bowel obstruction, perforation, internal or external fistulization or infection.
- Not willing to consent or follow guidelines throughout research trial.
- Screening labs in either donor or recipient reveal problems with performing fecal microbiome transplantation because inclusion requirements are no longer met.
- Physician discretion.
- Participant request.
DONOR EXCLUSION CRITERIA:
- A history of antibiotic treatment during the 3 months preceding donation.
- A history of intrinsic gastrointestinal illnesses.
- A history of autoimmune or atopic illness or modulating therapy.
- A history of chronic pain syndromes, or neurologic or neurodevelopmental disorders.
- Metabolic syndrome or malnutrition or obesity.
- A history of exposure to infectious agents.
- Diarrhea or other symptoms of an intestinal infection within two weeks prior to, or on the day of, stool donation.
- A history of malignant illnesses or ongoing oncologic therapy.
- Weight less than 15 kgs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fecal Microbiome Transplantation
Fecal Microbiome Transplantation will be done at the time of EGD and colonoscopy.
A parent or sibling or a healthy relative will be tested for several infections like hepatitis, H. Pylori, HIV, syphilis, ova and parasites, culture and C.diff.
They will fill out a donor questionnaire used for blood donors prior to the sample collection.
After eligibility criteria have been met, appropriate consent has been obtained, and the screening labs have been assessed, the fecal transplant procedure will take place in the procedure center at Children's Hospital of Pittsburgh.
Fresh stool sample will be obtained from the donor.
The fecal sample will be prepared for transplantation in a designated area in the procedure center.
Frequency: once.
Duration: Approximately 1 hour
|
The process of fecal microbiota transplantation (FMT), where fecal bacteria from a healthy individual is transferred into a recipient as an alternative therapy for individuals affected with these life-altering diseases: Crohn's Disease (CD), and/or Ulcerative Colitis (UC).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Occurrences of Adverse Events at 6 Months According to Adverse Event Term
Time Frame: 6 months
|
Adverse events recorded to determine safety of Fecal Microbiome Transplant in the treatment of children with IBD.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Examine the Efficacy of Fecal Microbiome Transplant in the Treatment of Children With IBD Using the Pediatric Ulcerative Colitis Activity Index (PUCAI) and the Pediatric Crohn Disease Activity Index (PCDAI) Analysis.
Time Frame: Baseline, Day 30, Day 180
|
Efficacy outcomes scored via Pediatric Ulcerative Colitis Activity Index (PUCAI) and the Pediatric Crohn Disease Activity Index (PCDAI) analysis. Scored at baseline, day 30, and at day 180 for responders. The PUCAI score range is 0-85, where the higher the number the more severe the disease (A score of 65 and up is considered severe, a score of 35-64 is considered moderate, and a score of 10-34 is considered mild). The PUCAI is the scoring system used for patients with ulcerative colitis/indeterminate colitis. The PCDAI score range is 0-100, where the higher the number the more severe the disease (A score of greater than 30 is considered moderate to severe, a score of 11-30 is considered mild, and a score of 10 or less is considered inactive disease). The PCDAI is the scoring system used for patients with crohn's disease. |
Baseline, Day 30, Day 180
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO13030081
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ulcerative Colitis (UC)
-
AbbVieNot yet recruitingUlcerative Colitis (UC)United States, Puerto Rico
-
TLA, Targeted Immunotherapies ABRecruitingUlcerative Colitis (UC)Sweden
-
AbbVieActive, not recruitingUlcerative Colitis (UC)United States, Australia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Norway, Puerto Rico, Spain, Sweden, United Kingdom
-
Theravance BiopharmaTerminatedUlcerative Colitis (UC)United States, Australia, Bulgaria, Canada, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Poland, Portugal, Romania, Serbia, Slovakia, South Africa, Spain, Taiwan, Ukraine
-
AbbVieCompletedUlcerative Colitis (UC)United States, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Poland, Romania, Slovakia, Spain, Switzerland, Ukraine, United Kingdom
-
Innovent Biologics (Suzhou) Co. Ltd.RecruitingUlcerative Colitis (UC)China
-
AbbVieActive, not recruitingUlcerative Colitis (UC)United States, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, New... and more
-
AbbVieCompletedUlcerative Colitis (UC)United States, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Nether... and more
-
AbbVieCompletedUlcerative Colitis (UC)United States, Canada, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Spain, United Kingdom
-
AbbVieCompletedUlcerative Colitis (UC)United States, Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea,... and more
Clinical Trials on Fecal Microbiota Transplantation (FMT)
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingAllogeneic Hematopoietic Stem CellUnited States
-
Massachusetts General HospitalCompleted
-
The Second Hospital of Nanjing Medical UniversityFuzhou General HospitalUnknown
-
University Hospital of North NorwayOslo University Hospital; Haukeland University Hospital; Sorlandet Hospital HF; Alesund HospitalActive, not recruitingIrritable Bowel SyndromeNorway
-
Susy HotaSinai Health System, Ontario, Canada; University of Toronto, Ontario, Canada; The Toronto Invasive Bacterial Diseases Network, Ontario, Canada and other collaboratorsSuspended
-
Brigham and Women's HospitalIcahn School of Medicine at Mount Sinai; The Miriam Hospital; Indiana UniversityCompletedInflammatory Bowel Diseases | Clostridium Difficile InfectionUnited States
-
Children's Hospital Los AngelesCompleted
-
Wiebke Kristin FenskeMedical University of GrazRecruitingDiabetes | Metabolic Syndrome | Insulin Resistance | PreDiabetes | Morbid ObesityAustria
-
Memorial Sloan Kettering Cancer CenterCompletedCancer | C. Difficile InfectionUnited States
-
The Third Affiliated Hospital of Southern Medical...Southern Medical University, ChinaUnknown