To longitudinally study the clinical efficacy of PUFA administration on the microbiome in hospitalized adolescents with AN in comparison to a placebo

Phase 2

• Conditions: F50.0; Anorexia nervosa

• Registration Number: DRKS00017130
• Lead Sponsor: Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-12
• Study Completion: 2023-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Female and male patients >=13 and <20
2. Written Informed consent.
3. Patient with typical and atypical anorexia nervosa according to DSM-5
4. Healthy control subjects without current psychiatric disorder according to ICD-10 and without eating disorders in the past.

Exclusion Criteria

1. Organic brain disease
2. psychotic disorder
3. bipolar disorder
4. substance use disorder
5. IQ < 80
6. insufficient knowledge of German language
7. Organic disorder with influence on gastrointestinal tract for example diabetes or inflammtory bowel diseases
8. antibiotic use during the previous 6 weeks.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Approximation of microbiome (MI) composition after PUFA (poly-unsaturated fatty acids) administration to that of heathly normal-weight age-matched controls which in consequence leads an increase in body weight as measured in body mass index.

Secondary Outcome Measures

Name	Time	Method
Secondarily, an improvement in gastrointestinal discomfort, a reduction in depressive symptoms and a reduction in inflammatory processes and intestinal permeability may be associated with these MI changes.