Fecal Transplant for C-diff Infection

(FMT Trial)

Overseen By Ling Fan, MPH

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Jonathan Gisser

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Severe comorbid condition, Severe colitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jonathan M. Gisser, M.D.

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

This trial is for children and young adults aged 2 to less than 21 years with recurrent C-diff infection, who are undergoing a colonoscopy. Participants must have had at least three episodes of this infection. Healthy first-degree relatives over 18 can be donors, but they shouldn't have taken antibiotics recently or have any listed health issues.

Inclusion Criteria

I haven't taken antibiotics in the last 3 months.

In 'low risk' category on modified DHQ (See above)

I have had c-diff infection three or more times.

Exclusion Criteria

I have severe symptoms or complications from a C. difficile infection and may have other serious health conditions.

I am on high-dose steroids or other immunosuppressive medications.

Recipient exclusion criteria: Severe comorbid condition (at discretion of the principal investigator)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 hour

1 visit (in-person)

Pre-transplant Evaluation

Evaluation of lab results from the participant and donor to ensure safety for fecal transplant

Up to 2 weeks

Fecal Transplant

Participants receive fecal microbiota transplantation via colonoscopy or enema

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment through phone calls

6 months

Phone calls at days 1, 7, 14, and months 1 and 6

Treatment Details

Interventions

• Fecal Microbiota Transplantation

Trial Overview The study tests fecal microbiota transplantation (FMT) in pediatric patients with recurrent C-diff infections. FMT involves transferring stool from a healthy donor into the patient's colon to balance the bacteria and combat the infection.

Participant Groups

Group I: Fecal Microbiota Transplantation Experimental Treatment 1 Intervention

250 ml of a fecal suspension diluted in saline given by colonoscopy or enema.

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

Approved in United States as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)

Approved in European Union as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)
• Other gastrointestinal disorders

Approved in Canada as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)

Who Is Running the Clinical Trial?

Jonathan Gisser

Lead Sponsor

Trials

1

Recruited

20+