Gut Bugs in Anorexia Nervosa

Not Applicable

Completed

• Conditions: Anorexia nervosa; Mental Health - Eating disorders

• Registration Number: ACTRN12621001504808
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-04
• Study Completion: 2023-11-27
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 17

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut microbiome structure (assessed with faecal samples and using Bray Curtis Dissimilarity)[ 3-weeks pre-treatment, baseline (i.e. day before treatment), 3-weeks post-treatment]