Fecal Microbiome Transplant

Launched by JUDITH KELSEN · Dec 17, 2015

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Fecal Microbiota Transplant (FMT) for children and young adults who have recurring or severe Clostridium Difficile (C. difficile) infections, and some of whom also have Inflammatory Bowel Disease (IBD) like Crohn's Disease or Ulcerative Colitis. The main goals are to see if FMT is safe and effective for these patients, and to learn how it changes the gut bacteria, which play an important role in our digestion and overall health.

To be eligible for this study, participants need to be aged between 3 and 21 years and have been diagnosed with IBD or have experienced recurrent or severe C. difficile infections. They will undergo a medical interview and physical exam to ensure they are suitable for the trial. If they join, they can expect to receive the FMT treatment and will have their gut microbiota analyzed before and after the procedure. This trial is currently recruiting participants, and safety measures are in place to protect their health throughout the study.

Gender

ALL

Eligibility 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