Fecal Transplant for Pediatric Patients Who Have Recurrent C-diff Infection
Status unconfirmed · Phase 1
Conditions studied: Clostridium Difficile
In brief
C-diff infection often causes belly pain and diarrhea and can be very hard to treat with medicine. One of the possible reasons that C-diff infection is hard to treat is because there is too much "bad" bacteria in the colon. Investigators believe that putting more "good" bacteria into the colon will help fight the "bad" bacteria. We do this by doing a fecal (poop) transplant. Fecal transplant has been done at other hospitals, but not at Nationwide Children's Hospital. Since our Investigators have not done this before, this study will help us learn the best way to do the transplant. Investigators also believe this transplant might help improve symptoms for patients with C-diff.
Key facts
- Study ID
- NCT02134392
- Run by
- Jonathan Gisser
- People needed
- 15
- Starts
- 2013-12-01
- Expected to finish
- 2025-01-01
- Last updated by the study team
- 2023-09-29
Who can join
Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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 it is running
- GI Division, Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.