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

NCT03928808 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: 18-1150
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (5)

• Proportion of Participants with Adverse Events (AEs)

  Safety 1

  Through day 30 (±3 days)

• Proportion of Participants with a Severe Adverse Event (SAE)

  Safety 2

  Through day 30 (±3 days)

• Number of Participants Recruited

  Feasibility 1, Ability to Recruit 10 Participants with SE-AN

  3 years

• Number of Participants Able to Complete 4 FMT Administrations

  Tolerability 1

  3 years

• Number of Participants Reporting Acceptable Levels of GI distress Post FMT

  Tolerability 2

  Through Week 4

Secondary Outcomes (6)

• Change in BMI Across Treatment and Follow-Up

  Pre-Treatment through Follow-Up (Month 6)

• Change in Percent Body Fat Across Treatment and Follow-Up

  Pre-Treatment through Follow-Up (Month 6)

• Eating Disorder Examination Questionnaire (EDE-Q) Scores over Time

  Pre-Treatment through Follow-Up (Month 6)

• PHQ-9 Scores Over Time

  Pre-Treatment through Follow-Up (Month 6)

• GAD-7 Scores Over Time

  Pre-Treatment through Follow-Up (Month 6)

Other Outcomes (1)

• FMT Transfer Efficiency

  Pre-Treatment through Follow-Up (Month 6)

Study Arms (1)

FMT for SE-AN

EXPERIMENTAL

Inpatients at the UNC-Chapel Hill Center of Excellence for Eating Disorders (CEED) and will receive weekly fecal microbiota transplantations for four weeks. This will be in addition to standard care at CEED.

Biological: Fecal Microbiota Transplantation (FMT)

Interventions

Fecal Microbiota Transplantation (FMT) BIOLOGICAL

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

Also known as: OpenBiome FMT Upper Delivery formulation, FMP30

FMT for SE-AN

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Female aged 18-45.
• Diagnosed with SE-AN, defined here as having suffered from AN for five or more years and having participated in two or more inpatient or residential treatment programs followed by weight relapse.
• Sufficiently medically stable to receive FMT (serum electrolytes within normal limits, normal EKG)
• Willing to adhere to the FMT dosing regimen.
• For females of reproductive potential, in sexual relationships with men, must use an acceptable method of contraception from 30 days prior to enrollment until 4 weeks after completing study treatment.\* Participants must also be willing to be subjected to periodic pregnancy tests.
• Agreement to adhere to Lifestyle Considerations throughout study duration.
• Adequate insurance to cover inpatient stay.
• Lifestyle Considerations: During this study, participants are asked to:
• Participate in standard inpatient treatment at UNC-Chapel Hill's CEED.
• Remain nil per os (npo) on the morning of each dosing session and for two hours after receiving FMT, on four individual instances of FMT administration.
• Abstain from sexual activity or use a condom or other form of highly effective birth control during the 30-day active stage of the clinical trial.
• Inform the research team as soon as possible if they become pregnant during the eight-week and six-month follow-up periods.
• If a trial participant has begun a course of one of this trial's prohibited medications during the eight-week or six-month follow-up periods, participants will be asked only to report the name of the medication, dose, and duration of treatment.

You may not qualify if:

• Male or outside of the 18-45 range
• Previous FMT or microbiome-based products at any time excluding this study
• Patients with allergies to ingredients Generally Recognized As Safe (GRAS)
• Patients with a history of severe anaphylactic or anaphylactoid food allergy
• Patient received antibiotics in the last 48 hours. Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to start of study
• Requires continued antibiotic use or anticipates antibiotic use in the upcoming 4 weeks
• Concurrent intensive induction chemotherapy, radiation therapy, or biological treatment for active malignancy.
• Pregnancy or lactation
• Febrile illness within past month
• Treatment with another investigational drug within the past month
• Alcohol or drug dependence either at time of the study or within the last year
• Active gastrointestinal infection at time of enrollment
• Any gastrointestinal or potentially intestinal microbiota-related conditions, including: Severe gastroparesis (e.g., gastric pacemaker) and any history of gastrointestinal illness (including but not limited to inflammatory bowel disease, irritable bowel syndrome, celiac disease, any gastrointestinal cancer, etc.)
• Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy
• Type 1 or 2 diabetes mellitus

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• OpenBiome: collaborator
• Foundation of Hope, North Carolina: collaborator

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Mary Kimmel, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Label Pilot Study

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 26, 2019
• Study Start: April 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication of the primary publication
• Access Criteria: To qualified applicants with documented IRB approval and analytic plan. A Data Use Agreement must be executed with UNC prior to actual sharing of data.

Locations

US (1)