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

Launched by JONATHAN GISSER · May 8, 2014

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called fecal transplant for children and young adults who have repeated infections from a germ called Clostridium difficile (C-diff). C-diff infections can cause significant belly pain and diarrhea, and they are often tough to treat with standard medications. The idea behind fecal transplant is to introduce more "good" bacteria into the gut, which may help fight off the "bad" bacteria causing the infection. This trial is important because it will help researchers learn the best way to perform this procedure specifically at Nationwide Children's Hospital.

To participate in this study, patients must be between the ages of 2 and 21 and have documented cases of C-diff infection with ongoing diarrhea. They should also be scheduled for a colonoscopy, which is a procedure to look inside the colon. The donors of the fecal material will typically be healthy adults, preferably close relatives, who have not taken antibiotics recently. Participants can expect to receive a fecal transplant as part of the study, and the goal is to see if this treatment can improve their symptoms. It's a new approach in this hospital, and the findings could lead to better care for children facing difficult-to-treat C-diff infections.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Recipient inclusion criteria:
• • Documented laboratory-confirmed clostridium difficile infection
• • Documentation of ongoing diarrhea at time of recruitment
• • Children ≥2 years old, \<18 years old; young adults \>18 years old, \<21 years old
• • Undergoing clinically-indicated colonoscopy
• • Recurrent c-diff infection (three or more occurrences)
• Donor inclusion criteria:
• • First-degree relative recommended, but not compulsory
• • ≥ 18 years old
• • In good health
• • No antibiotic use within the last 90 days
• • In "low risk" category on modified DHQ (See above)
• Exclusion Criteria:
• • Recipient exclusion criteria
• • Severe comorbid condition (at discretion of the principal investigator)
• • On immunosuppressive medications (high dose steroids 30 mg/kg of methylprednisolone)
• • Severe or fulminant C. difficile colitis
• • Toxic appearance
• • Signs of hemodynamic instability
• • Peritoneal signs on physical exam
• • Anemia on complete blood count
• • electrolyte imbalances on basic metabolic panel
• • 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.
• • History of severe anaphylactic shock
• Donor exclusion criteria:
• • Abnormal stools
• • Abdominal complaints
• • History of inflammatory bowel disease or gastrointestinal malignancy
• • Symptoms indicative of irritable bowel syndrome or other chronic pain syndromes (e.g. chronic fatigue syndrome, fibromyalgia)
• • History of systemic autoimmunity (e.g. multiple sclerosis, connective tissue disease)
• • Recent use of potent immunosuppressive medications (calcineurin inhibitors, exogenous glucocorticoids, biological agents, etc..)
• • Recent ingestion of a potential allergen (e.g. nuts) where recipient has a known allergy to this (these) agent(s)
• • Known communicable disease
• • Neurologic, neurodevelopmental or neurodegenerative disorders
• • History of malignancy
• • Has consumed any foods/medications to which the recipient is allergic within the designated period of time