Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · Dec 15, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the use of fecal microbiota transplantation (FMT) as a potential treatment for gastrointestinal (GI) issues in children and young adults who have had a hematopoietic cell transplant (HCT). The focus is on understanding how safe and feasible FMT is for treating gut problems caused by graft-versus-host disease (GvHD) or other digestive dysfunctions that can occur after HCT. Participants will be closely monitored to see if this treatment can help improve their GI symptoms.

To be eligible for the trial, participants must be under 22 years old and have experienced GI problems for at least four weeks after receiving an HCT. This could include conditions like ongoing diarrhea or the need for special feeding methods. The trial is currently recruiting participants, and those who join can expect to learn more about the process and receive support from the research team throughout their involvement. It's important to note that certain factors, like recent surgeries or specific health conditions, may prevent some individuals from participating in the study.

Gender

ALL

Eligibility 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.