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Fecal Microbiome Transplant

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ClinicalTrials.gov Identifier: NCT02636517
Recruitment Status : Recruiting
First Posted : December 21, 2015
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE December 16, 2015
First Posted Date  ICMJE December 21, 2015
Last Update Posted Date December 13, 2018
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2015)
Number of subjects with a recurrence of C. difficile (CDI) [ Time Frame: 7 days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02636517 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiome Transplant
Official Title  ICMJE Fecal Microbiome Transplant in Pediatric C. Difficile
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Clostridium Difficile
  • Inflammatory Bowel Disease
  • Crohn's Disease
  • Ulcerative Colitis
Intervention  ICMJE Biological: Fecal Microbiota Transplant
Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug
Study Arms  ICMJE
  • C. Difficile without IBD
    Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile
    Intervention: Biological: Fecal Microbiota Transplant
  • C. Difficile with IBD
    Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile with Inflammatory Bowel Disease
    Intervention: Biological: Fecal Microbiota Transplant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 17, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosis of Inflammatory Bowel Disease by colonoscopy, radiographic and clinic measures, as per standard protocol.
  2. Age ≥ 3 years old.
  3. Recurrent C. difficile or Moderate to Severe C. difficile.
  4. Satisfactory completion of the medical interview and physical exam conducted by a study team member
  5. Participants must be between 3 and 21 years of age (inclusive)
  6. Signed informed consent form, and assent (if applicable)

Exclusion Criteria:

  1. Patients <3 years old
  2. Patients with other co-morbid intestinal infectious processes
  3. Recipients with a history of severe (anaphylactic) food allergy
  4. 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.
  5. Patients with severe IBD.
  6. Ongoing/anticipated antibiotic use for non-CDI indication
  7. Adverse event attributable to a previous FMT
  8. Patients with allergies to sodium chloride or glycerol, both ingredients Generally Recognized As Safe (GRAS)
  9. Any other condition for which the treating physician thinks the treatment may pose a health risk
  10. Predicted death within time period of follow-up
  11. Patients who are on supraphysiologic doses of corticosteroids
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Judith Kelsen, MD 267-426-6822 kelsen@email.chop.edu
Contact: Melissa Kennedy, MD 267-426-1495 kennedym1@email.chop.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02636517
Other Study ID Numbers  ICMJE 13-010531
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Judith Kelsen, MD Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP