An open-label pilot trial of faecal microbiome transfer to restore the gut microbiome in anorexia nervosa

niversity of Auckland0 个研究点目标入组 17 人开始时间: 2021年11月4日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•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.
•- 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)

•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
•- 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

发起方

niversity of Auckland