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FMT in Pediatric Crohn’s Disease

September 12, 2019

Overview

This study’s goal is determining the safety of multiple factors that indicate remission in Children from Cron’s disease, including:

  • Fecal Microbiota Transplantation (FMT) in children with Crohn’s disease
  • Pediatric Crohn’s Disease Activity Index (PCDAI)
  • Changes in gut microbial diversity, an underexplored genetic and biological pool

 

50 grams of stools are donated from healthy donors into the jejunum, the part of the small intestine between the duodenum and ileum, through an upper endoscopy.

 

Study Information

The main goal of the trial is safety in children with Crohn’s disease who are in remission. This study is interventional and only studies findings from one group. Safety will be monitored through telephone calls, study visits, and adverse events over 24 weeks. Cron’s disease activity and changes in gut microbiome will also be monitored through through PCDAI scores.

 

Inclusion Criteria

  • All sexes, ages 7-21 years old
  • Diagnosed with Crohn’s disease
  • Remission of disease defined as a PCDAI score less than 10
  • Needs an upper GI endoscopy

 

Exclusion Criteria

  • Unwilling or unable to provide informed consent
  • Pregnancy and breastfeeding
  • Subjects with renal and liver dysfunction
  • Subjects with immunodeficiency, or who are 
  • Immunosuppressed due to neoplastic disease or organ transplantation
  • Have received or are receiving chemotherapy
  • Diagnosed with HIV.
  • Severe food allergies

 

Locations

You may participate in this study at the Children’s Hospital Los Angeles in Los Angeles, California, United States, 90027. If you have any questions or concerns, feel free to contact Sonia Michail, MD at 323-361-1353 or at sonia.michail@hotmail.com.

 

Sponsors/Collaborators

This clinical trial is sponsored by the Children’s Hospital Los Angeles and Sonia Michail, MD serves as the Principal Investigator.

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