Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fecal Microbiome Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Clostridium Difficile Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Biological: Fecal Microbiota Transplant Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiome Transplant in Pediatric C. Difficile
Study Start Date : December 2015
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
C. Difficile without IBD
Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile
 Biological: Fecal Microbiota Transplant
Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug
C. Difficile with IBD
Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile with Inflammatory Bowel Disease
 Biological: Fecal Microbiota Transplant
Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636517


Contacts
Layout table for location contacts
Contact: Judith Kelsen, MD 267-426-6822 kelsen@email.chop.edu
Contact: Melissa Kennedy, MD 267-426-1495 kennedym1@email.chop.edu

Locations
Layout table for location information
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Judith Kelsen, MD    267-426-6822    kelsen@email.chop.edu   
Contact: Melissa Kennedy, MD    267-426-1495    kennedym1@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Layout table for investigator information
Principal Investigator: Judith Kelsen, MD Children's Hospital of Philadelphia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02636517     History of Changes
Other Study ID Numbers: 13-010531
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Children's Hospital of Philadelphia:
Fecal Microbiota transplant

Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases