Using fecal microbiota transplantation to treat gastrointestinal issues in children after stem cell transplants
Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).
This study is testing whether giving fecal microbiota transplants can help children with gut problems after they’ve had a stem cell transplant.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | N/A to 22 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT05664113 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the feasibility, safety, and potential efficacy of fecal microbiota transplantation (FMT) for children experiencing gastrointestinal dysfunction following hematopoietic cell transplantation (HCT). Participants aged 22 years or younger who have undergone HCT and are experiencing specific gastrointestinal symptoms will receive FMT using material from OpenBiome. The procedure involves administering FMT via a nasojejunal tube and colonoscopy, with the possibility of a second treatment if symptoms do not improve. The study aims to assess both the safety and potential benefits of this innovative approach in managing gut-related complications post-transplant.
Who should consider this trial
Good fit: Ideal candidates are children under 22 years old who have undergone HCT and are experiencing steroid-resistant or steroid-dependent gut graft-versus-host disease or prolonged gastrointestinal dysfunction.
Not a fit: Patients who are not experiencing gastrointestinal issues following HCT or those with certain viral infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve gastrointestinal health and quality of life for children recovering from HCT.
How similar studies have performed: Other studies have shown promise in using fecal microbiota transplantation for gastrointestinal disorders, suggesting potential success for this approach in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Age \< 22 years old.
* Received an allogeneic HCT greater than or equal to 30 days prior to enrollment
* Diagnosed with one of the following conditions:
1. Steroid-resistant gut a GvHD (defined as GI symptoms that do not improve within 5 days after initial steroid therapy, \>/= 1mg/kg of prednisolone) OR
2. Steroid-dependent gut a GvHD (defined as the presence of a response to methylprednisolone 2 mg/kg/day but relapsing when an attempt was made to taper steroid treatment).
OR
3. Current or prolonged GI dysfunction following HCT, defined as having diarrhea or loose stools \>/= 4 weeks with at least one of the following:
1. Requiring NG or G-tube feeds
2. Requiring TPN or IVF for more than 4 weeks
3. Diagnosis of gastroparesis by GI specialist documented in the medical record
* Willing and able to provide informed assent/consent
Exclusion Criteria:
* Cytomegalovirus (CMV) or Epstein Barr Virus (EBV) IgG negative at the time of consent
* Female participant who is pregnant or nursing
* History of previous FMT
* Intra-abdominal surgery within 4 weeks of enrollment
* At increased risk for peritonitis: presence of intra-abdominal devices (G-or GJ-tubes are acceptable), receiving peritoneal dialysis, or ascites
* Concurrent abdominal radiation therapy
* Any acute or chronic illness/condition as well as medication that in the opinion of the investigator puts the subject at greater risk from FMT or may confound the study results.
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Gabriela Maron, MD — St. Jude Children's Research Hospital
- Study coordinator: Gabriela Maron, MD
- Email: referrainfo@stjude.org
- Phone: 866-278-5833
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.