Fecal Microbiota Transplantation (FMT) in Treatment of Severe and Enduring Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title: Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Severe and Enduring Anorexia Nervosa (SE-AN)

Status Withdrawn

Clinical Trial Summary

This is an open-label pilot study designed to explore the safety, feasibility, tolerability, and acceptability of fecal microbiota transplantation (FMT) in the treatment of severe and enduring anorexia nervosa (SE-AN).

Clinical Trial Description

Open-label investigation of 10 individuals seeking inpatient treatment for severe and enduring anorexia nervosa. In addition to standard inpatient treatment, patients receive one FMT per week for 4 weeks, with follow-ups at 8 weeks and 6 months. Patients will receive 30 mL of healthy fecal microbial preparation (OpenBiome, FMP30) into the upper GI tract via a nasogastric tube weekly for 4 weeks. Primary outcomes are to determine safety, feasibility, tolerability, and acceptability of FMT for the treatment of AN. Secondary outcomes are: to determine preliminary efficacy as indexed by weight gain and weight retention over follow-up; to assess positive change in psychological metrics; to measure the efficiency of microbial transfer from the FMT material to the recipient intestinal microbiota; and to determine the duration of this effect via repeat stool sampling paired with 16S rRNA gene and/or shallow shotgun metagenomics. ;

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

• NCT number: NCT03928808
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: April 1, 2023
• Completion date: September 2024