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Enrolling by Invitation

NCT Number: NCT02636517

Fecal Microbiome Transplant

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.

Enrolling by Invitation

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Key information

Conditions

Clostridium Difficile Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

3 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal Microbiota Transplant

Biological

Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Judith Kelsen

Other

Registry information

Official study title

Fecal Microbiome Transplant in Pediatric C. Difficile

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Dec 21, 2015
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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