An Early Phase 1 interventional study of Fecal Microbiota Transplantation (FMT) in Anorexia Nervosa, sponsored by University of North Carolina, Chapel Hill. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-01-30.
Sponsored by University of North Carolina, Chapel Hill · Early Phase 1, Interventional, and Other
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).
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.
411 studies on the registry are indexed under Anorexia; 67 are open to participants now.
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Adequate insurance to cover inpatient stay.
Lifestyle Considerations: During this study, participants are asked to:
Exclusion Criteria:
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)
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
Proportion of Participants with Adverse Events (AEs)
Safety 1
Time frame: Through day 30 (±3 days)
Proportion of Participants with a Severe Adverse Event (SAE)
Safety 2
Time frame: Through day 30 (±3 days)
Number of Participants Recruited
Feasibility 1, Ability to Recruit 10 Participants with SE-AN
Time frame: 3 years
Number of Participants Able to Complete 4 FMT Administrations
Tolerability 1
Time frame: 3 years
Number of Participants Reporting Acceptable Levels of GI distress Post FMT
Tolerability 2
Time frame: Through Week 4
Change in BMI Across Treatment and Follow-Up
BMI calculated as weight in kg / height in meters squared
Time frame: Pre-Treatment through Follow-Up (Month 6)
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.
Time frame: Pre-Treatment through Follow-Up (Month 6)
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.
Time frame: Pre-Treatment through Follow-Up (Month 6)
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.
Time frame: Pre-Treatment through Follow-Up (Month 6)
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.
Time frame: Pre-Treatment through Follow-Up (Month 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.
Time frame: Pre-Treatment through Follow-Up (Month 6)
FMT Transfer Efficiency
The investigators will establish which particular taxa of bacteria from the FMT material successfully engrafted into the recipient's intestinal tract. FMT transfer efficiency is the percentage of bacterial taxa that successfully transfer from the donor FMT to the FMT recipient's stool.
Time frame: Pre-Treatment through Follow-Up (Month 6)
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is withdrawn, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill