Fecal Microbiota Transplantation (FMT) in Treatment of Severe and Enduring Anorexia Nervosa
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|ClinicalTrials.gov Identifier: NCT03928808|
Recruitment Status : Suspended (Currently on partial clinical hold due to COVID-19 policies.)
First Posted : April 26, 2019
Last Update Posted : May 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa||Biological: Fecal Microbiota Transplantation (FMT)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open Label Pilot Study|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Severe and Enduring Anorexia Nervosa (SE-AN)|
|Estimated Study Start Date :||August 15, 2020|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||September 2022|
Experimental: FMT for SE-AN
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
- Proportion of Participants with Adverse Events (AEs) [ Time Frame: Through day 30 (±3 days) ]Safety 1
- Proportion of Participants with a Severe Adverse Event (SAE) [ Time Frame: Through day 30 (±3 days) ]Safety 2
- Number of Participants Recruited [ Time Frame: 3 years ]Feasibility 1, Ability to Recruit 10 Participants with SE-AN
- Number of Participants Able to Complete 4 FMT Administrations [ Time Frame: 3 years ]Tolerability 1
- Number of Participants Reporting Acceptable Levels of GI distress Post FMT [ Time Frame: Through Week 4 ]Tolerability 2
- Change in BMI Across Treatment and Follow-Up [ Time Frame: Pre-Treatment through Follow-Up (Month 6) ]BMI calculated as weight in kg / height in meters squared
- Change in Percent Body Fat Across Treatment and Follow-Up [ Time Frame: Pre-Treatment through Follow-Up (Month 6) ]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.
- Eating Disorder Examination Questionnaire (EDE-Q) Scores over Time [ Time Frame: Pre-Treatment through Follow-Up (Month 6) ]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.
- PHQ-9 Scores Over Time [ Time Frame: Pre-Treatment through Follow-Up (Month 6) ]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.
- GAD-7 Scores Over Time [ Time Frame: Pre-Treatment through Follow-Up (Month 6) ]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.
- PROMIS-GI Scores Over Time [ Time Frame: Pre-Treatment through Follow-Up (Month 6) ]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.
- FMT Transfer Efficiency [ Time Frame: Pre-Treatment through Follow-Up (Month 6) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928808
|United States, North Carolina|
|UNC Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Mary Kimmel, MD||University of North Carolina, Chapel Hill|