Fecal transplant for kids with recurrent C-diff infection
Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection (CDI) in Pediatric and Young Adult Patients
This study is testing whether a fecal transplant can help kids with repeated C-diff infections by introducing good bacteria into their gut.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 2 Years to 21 Years |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT02134392 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of fecal microbiota transplantation (FMT) to treat pediatric patients suffering from recurrent Clostridium difficile infections. The study aims to introduce beneficial bacteria into the colon to combat the harmful bacteria causing the infection. Participants will undergo a screening process to ensure eligibility, followed by a fecal transplant procedure, which may be administered via enema or colonoscopy. The trial is being conducted at Nationwide Children's Hospital, where the methodology will be refined based on the outcomes observed.
Who should consider this trial
Good fit: Ideal candidates include children aged 2 to 21 years with documented recurrent C-diff infections and ongoing diarrhea.
Not a fit: Patients with severe comorbid conditions or those on immunosuppressive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the health and quality of life for children suffering from recurrent C-diff infections.
How similar studies have performed: Other studies have shown success with fecal microbiota transplantation for C-diff infections, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- GI Division, Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan M. Gisser, M.D. — Nationwide Children's Hospital
- Study coordinator: Ling Fan, MPH
- Email: ling.fan@nationwidechildrens.org
- Phone: 614-722-3412
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.