None listed
Conditions
Brief summary
Background Individuals with anorexia nervosa harbour distinct gut microbiomes compared to healthy individuals, which are sufficient to induce weight loss and anxiety-like behaviours when transplanted into germ-free mice. Hypothesis We hypothesise that faecal microbiome transfer (FMT) from healthy donors will help restore the gut microbiomes of individuals with anorexia nervosa which may aid patient recovery. Study design and aims We plan to conduct an open-label pilot study to assess the safety, tolerability, and efficacy of FMT to restore the gut microbiome in adolescents and young adults with anorexia nervosa. Participants We aim to recruit 20 females, aged 16-32 years, who meet the DSM-5 criteria for anorexia nervosa and have a BMI 13-19 kg/m2. Donors We will also recruit four healthy, lean, female “super-donors”, aged 18-32 years, who will undergo extensive clinical screening prior to stool donation. Intervention Faecal microbiota will be harvested from four donors and double encapsulated in delayed release, acid-resistant capsules. All participants will receive a single course of 20 FMT capsules which they can choose to take over two or four consecutive days. Assessments Stool and blood samples will be collected from participants over a period of 3 months to monitor changes in their gut microbiome profile, gut inflammation/permeability, and nutritional/metabolic status. Our primary outcome is a shift in the gut microbiome composition at 3 weeks post-FMT (shotgun metagenomic sequencing). We will also measure changes in participants body composition (DXA-scan), eating disorder psychopathology (EDEQ questionnaire), mental health (PHQ9 & GAD-7 questionnaires), and assess their views and tolerability to treatment. All adverse events will be recorded and reviewed by a data monitoring committee.
Interventions
Participants will receive 20 capsules containing the gut microbiota derived from four healthy, clinically-screened female stool donors. Each capsule contains 0.5 grams concentrated gut microbiota suspended in a cryoprotective solution (0.9% saline + 15% glycerol). Capsules will be swallowed with a glass of water under direct supervision from a research clinician or nurse. The dose will be split over two or four consecutive mornings depending on participant preference (i.e. 10 capsules/day or 5 c
Participants will receive 20 capsules containing the gut microbiota derived from four healthy, clinically-screened female stool donors. Each capsule contains 0.5 grams concentrated gut microbiota suspended in a cryoprotective solution (0.9% saline + 15% glycerol). Capsules will be swallowed with a glass of water under direct supervision from a research clinician or nurse. The dose will be split over two or four consecutive mornings depending on participant preference (i.e. 10 capsules/day or 5 capsules/day, all taken at the same time).
Sponsors
University of Auckland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to 32 Years
Healthy volunteers
Yes
Inclusion criteria
Participants: - Biological female - Age 16 – 32 years - BMI 13 - 19 kg/m2 - formal diagnosis of anorexia nervosa by an eating disorder specialist (meets the DSM-5 criteria, 307.1) - Medically stable - Be able and willing to swallow treatment capsules and comply with the clinical assessments. Donors: - Female - Age 18-32 years - BMI 18.5 - 25.0 kg/m2 - Total body fat less than or equal to 33% - Healthy diet (greater than or equal to 4 portions of fruit and vegetables per day) - Regular exercise (moderate to vigorous physical activity for at least 3.5 hours per week) - Regular bowel habit (at least once every two days)
Exclusion criteria
Participants: - Known allergies to food and/or common medications - Use of antibiotics or probiotics in the month prior to treatment - Regular oral steroid treatment or daily application of potent topical steroids extensively to the body - Compromised immune system -Any chronic illness affecting gut or metabolic health - Thoughts of self-harm and/or suicide ideation (assessed by PHQ-9) - Current or planned pregnancy during the course of the study Donors: - Positive screening test for any transmissible pathogen or multi-drug resistant organism - Gastrointestinal disease (e.g. inflammatory bowel disease, irritable bowel syndrome, coeliac disease, eosinophilic oesophagitis) - Metabolic disorder (e.g. diabetes, metabolic syndrome, hypertension, dyslipidemia, dysglycemia) - Impaired fasting glucose (>5.9 mmol/l) or elevated HbA1c (>41 mmol/mol) - Asthma or eczema requiring regular prophylaxis or treatment - Autism spectrum conditions - Previous diagnosis of mental health issues including eating disorders - Current or past history of malignancy - Use of oral antibiotics or probiotics in the past 3 months - Regular binge drinking (>5 standard alcoholic units/session at least once a week) - Past or present use of recreational drugs, tobacco, or vaping - Current or past pregnancy - Overseas travel in the past 2 weeks - UK residence in 1980-1996 for 6 months or longer
Outcome results
None listed