Fecal Microbiome Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fecal Microbiota Transplant.
- Who it may be relevant to
- Registry conditions: Clostridium Difficile, Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis. Basic parameters: 3 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Fecal Microbiome Transplant in Pediatric C. Difficile
Overview
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.
Interventions
- Biological Fecal Microbiota Transplant
Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug
Primary outcome measures
- Number of subjects with a recurrence of C. difficile (CDI) [Time frame: 7 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Children's Hospital of Philadelphia — Philadelphia
Identifiers
NCT: NCT02636517 · 13-010531