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Anorexia NervosaEarly Phase 1NCT03928808

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

A Early Phase 1 study testing Fecal Microbiota Transplantation (FMT) in people with Anorexia Nervosa, run by University of North Carolina, Chapel Hill at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Anorexia Nervosa
What is being tested?
Fecal Microbiota Transplantation (FMT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Apr 2023to Sep 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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
  • Known or suspected toxic megacolon and/or known small bowel ileus
  • History of total colectomy or bariatric surgery
  • Solid organ transplant recipients less than or equal to 90 days posttransplant or on active treatment for rejection
  • If at risk for CMV/EBV associated disease (at investigator's discretion, e.g. immunocompromised), negative IgG testing for cytomegalovirus (CMV) or Epstein-Barr Virus (EBV).
  • Patients who are immunocompromised
  • Unable or unwilling to comply with protocol requirements
  • Expected life expectancy < 6 months
  • A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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

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).

Read the detailed 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.

Being tested
Fecal Microbiota Transplantation (FMT)
Keywords
Fecal Microbiota Transplantation
Medical subject headings
Anorexia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal Microbiota Transplantation (FMT)Biological

    Also called OpenBiome FMT Upper Delivery formulation, FMP30

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

Study groups in NCT03928808
Study groupRoleWhat they receive
FMT for SE-ANExperimentalInpatients 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.
Receives: Biological: Fecal Microbiota Transplantation (FMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants with Adverse Events (AEs)

    Safety 1

    Measured: Through day 30 (±3 days)

  2. Proportion of Participants with a Severe Adverse Event (SAE)

    Safety 2

    Measured: Through day 30 (±3 days)

  3. Number of Participants Recruited

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

    Measured: 3 years

  4. Number of Participants Able to Complete 4 FMT Administrations

    Tolerability 1

    Measured: 3 years

  5. Number of Participants Reporting Acceptable Levels of GI distress Post FMT

    Tolerability 2

    Measured: Through Week 4

Secondary outcomes (6)

  1. Change in BMI Across Treatment and Follow-Up

    BMI calculated as weight in kg / height in meters squared

    Measured: Pre-Treatment through Follow-Up (Month 6)

  2. Change in Percent Body Fat Across Treatment and Follow-Up

    Body fat percentage (to the nearest 0.1%) will be measured using a Tanita Dual Frequency Total Body Composition Analyzer that assesses weight and bioelectrical impedance for adiposity.

    Measured: Pre-Treatment through Follow-Up (Month 6)

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

    The EDE-Q is a 28-item questionnaire measuring eating pathology and is derived directly from the Eating Disorder Examination Interview. The EDE-Q focuses on the past 28 days to assess the main behavioral (eating and purging) and attitudinal features of eating disorders. The 28 items are rated by the participant on a 7-point scale (ranging from 0 to 6), with higher scores indicating increased pathology. The EDE-Q includes 4 subscales: Restraint, Eating Concern, Weight Concern, and Shape Concern. The global score is the average of all 28 items, with a range of 0 to 6.

    Measured: Pre-Treatment through Follow-Up (Month 6)

  4. PHQ-9 Scores Over Time

    The Patient Health Questionnaire (PHQ-9) has 9 items with each rated from 0 to 3. Overall scores ranges from 0 to 27 with 1-4 being minimal depression, 5-9 being mild depression, 10-14 being moderate depression, 15-19 being moderately severe depression and 20-27 being severe depression.

    Measured: Pre-Treatment through Follow-Up (Month 6)

  5. GAD-7 Scores Over Time

    Anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7) 7-item scale. The range of the measure is 0 to 21, with higher scores indicating greater anxiety symptoms.

    Measured: Pre-Treatment through Follow-Up (Month 6)

  6. PROMIS-GI Scores Over Time

    Self-reported outcome of GI symptom burden measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) gastro-intestinal (GI) Symptoms scale on the study iPad. The scale includes 4 items and responses to each item are on a 1 (Never) to 5 (Almost Always) scale. Higher scores indicate greater GI symptom burden.

    Measured: Pre-Treatment through Follow-Up (Month 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2019
  2. Study start1 Apr 2023 (estimated)
  3. Primary completionMar 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Why it stopped: Withdrawn due to covid-19 protocols on inpatient eating disorders unit.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Open Label Pilot Study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03928808
Sponsor's protocol ID
18-1150
Status last verified
Jan 2023
First submitted
23 Apr 2019
Last updated
30 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual participant data (IPD) will be made available by controlled access. Qualified researchers with documented evidence of ethical approval and a clear research and statistical analysis plan will be given access through a secure file transfer protocol (FTP) site. Data to be shared include diagnostic information, age, non-identifying demographic data (including BMI and other anthropometric measures), psychometric, and sequence data along with a data dictionary.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Fecal Microbiota Transplantation (FMT) in people with Anorexia Nervosa, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants with Adverse Events (AEs) (time frame: Through day 30 (±3 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03928808.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.

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