Skip to Main Content
Recruiting

NEWGUT: Fecal Microbiota Transplantation After BMT

About this study

When children get a bone marrow transplant (also called a stem cell transplant or hematopoietic cell transplant), their digestive system can stop working well. This problem can happen because of damage from the transplant or from a condition called gastrointestinal (GI) graft-versus-host disease (GVHD)

Our gut has many helpful microbes that help digest food, fight bad germs, and support a healthy gut lining. Treatments used during transplant—like antibiotics or chemotherapy—can damage or change these helpful microbes. This imbalance can cause diarrhea, pain, and trouble eating or absorbing nutrients. Right now, there are not many good treatments for this. Doctors need new ways to help these children get better.

This study is testing a treatment called fecal microbiota transplantation (FMT). FMT uses stool from a carefully screened, healthy donor to add diverse microbes to the patient’s intestines. The hope is that these helpful microbes can restore balance in the digestive system. This may reduce symptoms and improve recovery after transplant.

Each child may receive 1 or 2 FMT treatments. Each treatment is given in the hospital using 2 methods:

  • Through a tube that goes past the stomach into the small intestine 
  • Through a colonoscopy into the large intestine. 

After treatment, the study team will check the child’s health for several months and call again at 1 year to look for any late side effects.

At the end of the trial, we hope to know whether FMT is a safe and workable treatment for gut problems after a bone marrow transplant in children. We also want to learn if it helps fix their digestive issues and how strong that help is. If it works and is safe, this could become a new treatment option.

Eligibility overview

  • 0–21 years old
  • Had a bone marrow transplant at least 30 days ago
  • Has steroid-resistant or steroid-dependent gastrointestinal graft-versus-host disease 

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

NEWGUT: Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation for Gastrointestinal Acute Graft-versus-host Disease in Children Following Hematopoietic Cell Transplant

Study goal:

To study fecal microbiota transplantation for steroid-resistant or steroid-dependent gastrointestinal graft-versus-host disease in children after hematopoietic cell transplant.

Diagnosis:

Steroid-resistant or steroid-dependent gastrointestinal graft-versus-host disease after bone marrow or stem cell transplant

Age:

0–21 years

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

Learn more