Fecal Microbiota Transplant for Clostridium Difficile and IBD
Trial Summary
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, ongoing or anticipated antibiotic use for non-CDI indications is an exclusion criterion, so you may need to stop those. Please consult with the study team for more details.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude patients who are on high doses of corticosteroids or those using antibiotics for reasons other than C. difficile. It's best to discuss your specific medications with the study team.
What data supports the idea that Fecal Microbiota Transplant for Clostridium Difficile and IBD is an effective treatment?
The available research shows that Fecal Microbiota Transplant (FMT) is a safe and effective treatment for recurrent Clostridium difficile infection (CDI). Studies have shown that FMT works well for patients with CDI, even if they also have inflammatory bowel disease (IBD). While the data on using FMT specifically for IBD is still being explored, there is promise that it could be beneficial. Compared to other treatments for CDI, FMT has been proven to be very effective in managing the infection, making it a recommended option.12345
What data supports the effectiveness of the treatment Fecal Microbiota Transplant for Clostridium Difficile and IBD?
Fecal Microbiota Transplant (FMT) is shown to be a safe and effective treatment for recurrent Clostridioides difficile infection, and there is emerging evidence suggesting it may also help patients with inflammatory bowel disease (IBD) who have this infection. Research indicates that changes in gut bacteria are linked to IBD, and FMT is being actively studied for its potential benefits in treating IBD itself.12345
What safety data exists for fecal microbiota transplant (FMT)?
FMT is generally considered safe and effective for treating recurrent Clostridium difficile infections, even in high-risk patients. Most short-term risks are mild and related to delivery methods. Long-term side effects have not been established, and no significant harm has been found to date. However, there have been serious adverse events linked to FMT products from stool banks lacking screening for multi-drug resistant organisms. Safety data for FMT in patients with inflammatory bowel disease (IBD) is emerging but remains limited and sometimes conflicting.36789
Is Fecal Microbiota Transplantation (FMT) safe for humans?
FMT is generally considered safe and well-tolerated, even in high-risk patients, with most short-term risks being mild. However, serious adverse events have been associated with FMT products from stool banks that do not screen for multi-drug resistant organisms, so strict donor screening is important.36789
Is Fecal Microbiota Transplant a promising treatment for Clostridium Difficile and IBD?
Yes, Fecal Microbiota Transplant (FMT) is a promising treatment. It is recommended for recurring Clostridium difficile infections and shows potential for treating inflammatory bowel diseases like ulcerative colitis and Crohn's disease. Studies suggest FMT is safe and effective, and ongoing research is exploring its benefits for these conditions.1341011
How is fecal microbiota transplant (FMT) different from other treatments for Clostridium difficile and IBD?
Fecal microbiota transplant (FMT) is unique because it involves transferring stool from a healthy donor to a patient to restore the balance of bacteria in the gut, which is different from traditional treatments that often rely on antibiotics or other medications. This approach is particularly novel for conditions like inflammatory bowel disease (IBD), where altering the gut microbiome may help manage symptoms.1341011
What is the purpose of this trial?
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.
Research Team
Judith Kelsen, MD
Principal Investigator
Children's Hospital of Philadelphia
Eligibility Criteria
This trial is for kids and young adults aged 3-21 with recurrent C. difficile or moderate to severe cases, who may also have Inflammatory Bowel Disease (IBD). They must pass a medical interview and physical exam, not be pregnant if female of childbearing age, and not have other intestinal infections or allergies to certain safe ingredients.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Fecal Microbiota Transplant (FMT) to treat recurrent C. Difficile with or without Inflammatory Bowel Disease
Follow-up
Participants are monitored for safety and effectiveness after FMT treatment
Treatment Details
Interventions
- Fecal Microbiota Transplant
Fecal Microbiota Transplant is already approved in United States, European Union, Canada for the following indications:
- Recurrent and refractory Clostridioides difficile infection
- Recurrent and refractory Clostridioides difficile infection
- Recurrent and refractory Clostridioides difficile infection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital of Philadelphia
Lead Sponsor
Judith Kelsen
Lead Sponsor