Fecal Microbiome Transplant
Primary Purpose
Clostridium Difficile, Inflammatory Bowel Disease, Crohn's Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fecal Microbiota Transplant
Sponsored by
About this trial
This is an interventional treatment trial for Clostridium Difficile focused on measuring Fecal Microbiota transplant
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Inflammatory Bowel Disease by colonoscopy, radiographic and clinic measures, as per standard protocol.
- Age ≥ 3 years old.
- Recurrent C. difficile or Moderate to Severe C. difficile.
- Satisfactory completion of the medical interview and physical exam conducted by a study team member
- Participants must be between 3 and 21 years of age (inclusive)
- Signed informed consent form, and assent (if applicable)
Exclusion Criteria:
- Patients <3 years old
- Patients with other co-morbid intestinal infectious processes
- Recipients with a history of severe (anaphylactic) food allergy
- If female, participants of childbearing potential (females aged 11 and older or those who have already begun menstruating) will be required to have a urine pregnancy test on the day of the FMT procedure. Patients who are pregnant will not be enrolled.
- Patients with severe IBD.
- Ongoing/anticipated antibiotic use for non-CDI indication
- Adverse event attributable to a previous FMT
- Patients with allergies to sodium chloride or glycerol, both ingredients Generally Recognized As Safe (GRAS)
- Any other condition for which the treating physician thinks the treatment may pose a health risk
- Predicted death within time period of follow-up
- Patients who are on supraphysiologic doses of corticosteroids
Sites / Locations
- Children's Hospital of PhiladelphiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
C. Difficile without IBD
C. Difficile with IBD
Arm Description
Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile
Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile with Inflammatory Bowel Disease
Outcomes
Primary Outcome Measures
Number of subjects with a recurrence of C. difficile (CDI)
The hypothesis is that FMT will be an effective therapy for patients with IBD and CDI, resulting in resolution of symptoms as compared to historical controls on antibiotic therapy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02636517
Brief Title
Fecal Microbiome Transplant
Official Title
Fecal Microbiome Transplant in Pediatric C. Difficile
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Judith Kelsen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fecal Microbiota Transplant (FMT) in pediatric patients with recurrent C. Difficile with or without Inflammatory Bowel Disease (IBD)
The aims of this study are to determine the safety and efficacy of FMT treatment in pediatric patients with recurrent or moderate to severe C. Difficile without (through an observational study) and with (through a clinical trial) Inflammatory Bowel Disease and to determine the effect of FMT on the gut microbiota through the use of 454 pyrosequencing before and after transplantation in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile, Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
Keywords
Fecal Microbiota transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
C. Difficile without IBD
Arm Type
Other
Arm Description
Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile
Arm Title
C. Difficile with IBD
Arm Type
Other
Arm Description
Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile with Inflammatory Bowel Disease
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiota Transplant
Intervention Description
Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug
Primary Outcome Measure Information:
Title
Number of subjects with a recurrence of C. difficile (CDI)
Description
The hypothesis is that FMT will be an effective therapy for patients with IBD and CDI, resulting in resolution of symptoms as compared to historical controls on antibiotic therapy.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Inflammatory Bowel Disease by colonoscopy, radiographic and clinic measures, as per standard protocol.
Age ≥ 3 years old.
Recurrent C. difficile or Moderate to Severe C. difficile.
Satisfactory completion of the medical interview and physical exam conducted by a study team member
Participants must be between 3 and 21 years of age (inclusive)
Signed informed consent form, and assent (if applicable)
Exclusion Criteria:
Patients <3 years old
Patients with other co-morbid intestinal infectious processes
Recipients with a history of severe (anaphylactic) food allergy
If female, participants of childbearing potential (females aged 11 and older or those who have already begun menstruating) will be required to have a urine pregnancy test on the day of the FMT procedure. Patients who are pregnant will not be enrolled.
Patients with severe IBD.
Ongoing/anticipated antibiotic use for non-CDI indication
Adverse event attributable to a previous FMT
Patients with allergies to sodium chloride or glycerol, both ingredients Generally Recognized As Safe (GRAS)
Any other condition for which the treating physician thinks the treatment may pose a health risk
Predicted death within time period of follow-up
Patients who are on supraphysiologic doses of corticosteroids
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judith Kelsen, MD
Phone
267-426-6822
Email
kelsen@chop.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Kennedy, MD
Phone
267-426-1495
Email
kennedym1@chop.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Kelsen, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Kelsen, MD
Phone
267-426-6822
Email
kelsen@chop.edu
First Name & Middle Initial & Last Name & Degree
Melissa Kennedy, MD
Phone
267-426-1495
Email
kennedym1@chop.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fecal Microbiome Transplant
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