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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Nasogastric administration of OpenBiome 25 g/mL solution administered nasogastrically once weekly for 4 consecutive weeks
UNC Chapel Hill
Chapel Hill, North Carolina, United States
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.
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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)