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

NCT03928808 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2023-01-30

No results posted yet for this study

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).

Conditions

  • Anorexia Nervosa

Interventions

BIOLOGICAL

Fecal Microbiota Transplantation (FMT)

Nasogastric administration of OpenBiome 25 g/mL solution administered nasogastrically once weekly for 4 consecutive weeks

Sponsors & Collaborators

  • OpenBiome

    collaborator INDUSTRY

  • Foundation of Hope, North Carolina

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Mary Kimmel, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-03-31
Completion
2024-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03928808 on ClinicalTrials.gov