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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00017130
Enrollment
60
Registered
2019-11-12
Start date
2020-01-15
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F50.0

Interventions

Group 1: freely available vegan PUFA (Docosahexaensäure (DHA) 1500mg/Eicosapentaensäure (EPA) 900mg) incl. 15mcg Vit. D3 („Opti3 Omega3 EPA&DHA), two times a day Group 2: Placebo

Sponsors

Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 20 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactJochen Seitz

Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters, Uniklinik RWTH Aachen

jseitz@ukaachen.de0241/8089171

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 12, 2026