250 Participants Needed

Fecal Microbiota Transplant for Clostridium Difficile and IBD

JK
MK
Overseen ByMelissa Kennedy, MD
Age: < 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Children's Hospital of Philadelphia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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

JK

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

Signed informed consent form, and assent (if applicable)
I have been diagnosed with Inflammatory Bowel Disease through tests.
I have had C. difficile infection more than once or it is severe.
See 3 more

Exclusion Criteria

Any other condition for which the treating physician thinks the treatment may pose a health risk
Predicted death within time period of follow-up
I am taking high doses of steroids.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Fecal Microbiota Transplant (FMT) to treat recurrent C. Difficile with or without Inflammatory Bowel Disease

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after FMT treatment

4 weeks

Treatment Details

Interventions

  • Fecal Microbiota Transplant
Trial Overview The study tests Fecal Microbiota Transplant (FMT) in children with C. difficile, observing its safety and effectiveness alone or when combined with IBD. It also examines changes in gut bacteria through advanced sequencing before and after the transplant.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: C. Difficile without IBDExperimental Treatment1 Intervention
Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile
Group II: C. Difficile with IBDExperimental Treatment1 Intervention
Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile with Inflammatory Bowel Disease

Fecal Microbiota Transplant is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Fecal Microbiota Transplantation for:
  • Recurrent and refractory Clostridioides difficile infection
🇪🇺
Approved in European Union as Faecal Microbiota Transplantation for:
  • Recurrent and refractory Clostridioides difficile infection
🇨🇦
Approved in Canada as Fecal Microbiota Transplantation for:
  • Recurrent and refractory Clostridioides difficile infection

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials
749
Recruited
11,400,000+

Judith Kelsen

Lead Sponsor

Trials
1
Recruited
250+

Findings from Research

In a review of 12 published studies on fecal microbiota transplantation (FMT) for inflammatory bowel disease (IBD), only one study suggested a significant donor effect, while the majority showed no statistically significant differences in efficacy based on donor material.
Despite the lack of strong evidence for donor effects, the study highlights that the existing data cannot completely rule out their potential clinical importance, indicating a need for larger, well-designed trials to explore this further.
Re-Evaluating the Evidence for Faecal Microbiota Transplantation 'Super-Donors' in Inflammatory Bowel Disease.Olesen, SW., Gerardin, Y.[2021]
Faecal microbiota transplantation (FMT) shows an initial cure rate of 81% and an overall cure rate of 89% for Clostridium difficile infection (CDI) in patients with inflammatory bowel disease (IBD), based on a systematic review of nine cohort studies involving 346 patients.
The recurrence rate of CDI after FMT in these patients is 19%, and there is no significant difference in cure rates between patients with IBD and those without, indicating that FMT is an effective treatment option for CDI in IBD patients.
Effect of Faecal Microbiota Transplantation for Treatment of Clostridium difficile Infection in Patients With Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis of Cohort Studies.Chen, T., Zhou, Q., Zhang, D., et al.[2022]
Fecal microbiota transplantation (FMT) is highly effective for treating recurrent Clostridioides difficile infection (CDI) in patients with inflammatory bowel disease (IBD), with an overall pooled cure rate of 88% after single and multiple FMTs based on a systematic review of 457 adult patients.
While FMT is effective, there is a 26.8% rate of IBD flare-ups following the procedure, indicating that while it helps with CDI, monitoring for IBD symptoms is important after treatment.
Outcomes of Fecal Microbiota Transplantation for C. difficile Infection in Inflammatory Bowel Disease : A Systematic Review and Meta-analysis.Tariq, R., Syed, T., Yadav, D., et al.[2023]

References

Re-Evaluating the Evidence for Faecal Microbiota Transplantation 'Super-Donors' in Inflammatory Bowel Disease. [2021]
Effect of Faecal Microbiota Transplantation for Treatment of Clostridium difficile Infection in Patients With Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis of Cohort Studies. [2022]
Outcomes of Fecal Microbiota Transplantation for C. difficile Infection in Inflammatory Bowel Disease : A Systematic Review and Meta-analysis. [2023]
FMT: What's Next? A Narrative Review of Fecal Microbiota Transplantation in Clostridioides difficile Infection and Inflammatory Bowel Disease. [2022]
Faecal Microbiota Transplantation is a simple, effective and safe treatment in the management of C. difficile infection in daily clinical practice. [2023]
Durability and Long-term Clinical Outcomes of Fecal Microbiota Transplant Treatment in Patients With Recurrent Clostridium difficile Infection. [2022]
Adverse events of fecal microbiota transplantation: a meta-analysis of high-quality studies. [2022]
The Current Landscape and Lessons from Fecal Microbiota Transplantation for Inflammatory Bowel Disease: Past, Present, and Future. [2022]
Fecal Microbiota Transplantation: Is It Safe? [2021]
[Patient perception and approval of fecal microbiota transplantation (FMT) as an alternative treatment option for ulcerative colitis]. [2022]
Faecal microbiota transplantation for Clostridium difficile infection. [2020]
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