RECRUITING

Fecal Transplant for Pediatric Patients Who Have Recurrent C-diff Infection

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

C-diff infection often causes belly pain and diarrhea and can be very hard to treat with medicine. One of the possible reasons that C-diff infection is hard to treat is because there is too much "bad" bacteria in the colon. Investigators believe that putting more "good" bacteria into the colon will help fight the "bad" bacteria. We do this by doing a fecal (poop) transplant. Fecal transplant has been done at other hospitals, but not at Nationwide Children's Hospital. Since our Investigators have not done this before, this study will help us learn the best way to do the transplant. Investigators also believe this transplant might help improve symptoms for patients with C-diff.

Official Title

Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection (CDI) in Pediatric and Young Adult Patients

Quick Facts

Study Start:2013-12
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02134392

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Recipient exclusion criteria
  2. * Severe comorbid condition (at discretion of the principal investigator)
  3. * On immunosuppressive medications (high dose steroids 30 mg/kg of methylprednisolone)
  4. * Severe or fulminant C. difficile colitis
  5. * Toxic appearance
  6. * Signs of hemodynamic instability
  7. * Peritoneal signs on physical exam
  8. * Anemia on complete blood count
  9. * electrolyte imbalances on basic metabolic panel
  10. * Considerations for Increased Risk of Adverse Events Should Be Given to patients with decompensated liver cirrhosis, advanced HIV/acquired immune deficiency syndrome, recent bone marrow transplant, or other cause of severe immunodeficiency.
  11. * History of severe anaphylactic shock

Contacts and Locations

Study Contact

Ling Fan, MPH
CONTACT
614-722-3412
ling.fan@nationwidechildrens.org

Principal Investigator

Jonathan M. Gisser, M.D.
PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital

Study Locations (Sites)

GI Division, Nationwide Children's Hospital
Columbus, Ohio, 43205
United States

Collaborators and Investigators

Sponsor: Jonathan Gisser

  • Jonathan M. Gisser, M.D., PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-12
Study Completion Date2025-01

Study Record Updates

Study Start Date2013-12
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

  • C-diff
  • Clostridium difficile
  • Fecal Transplant
  • FMT
  • Fecal Microbiota Transplant

Additional Relevant MeSH Terms

  • Clostridium Difficile