Anorexia Nervosa Clinical Trial
— EATOfficial title:
Τhe Effect of Nutritional rEhabilitation in Patients With Anorexia Nervosa on Markers Associated With Disease severiTy
The design of this project is a longitudinal trial in patients with Anorexia Nervosa (AN) during in-hospital rehabilitation. Τhe structure of the study, the questionnaires and data protection policy prepared exclusively for our study, have been reviewed and standardised at Institutional Review Boards (Ethics Committees, IRBs,) in Harokopio University of Athens (HUA), Eginition Hospital (EH), Attiko Hospital (AH) and Sismanoglio Hospital (SG). AN is a psychiatric disorder followed by a psychopathologic concerning of body image and very low body weight due to extreme self-starvation. The exact pathogenesis of AN remains unknown with neurobiological, gastrointestinal, neuroendocrinological, immunological, and genetic factors suspected to be implicated. Furthermore, many metabolic traits, biochemical, biological or/and anthropometrical, are manifested during the maintaining effort of patients to achieve lower body weight. Self-inflicted starvation is the primary and essential causation of the pathological outcomes of the disorder. These outcomes involve all biological systems and organs. The role of the immune system in AN is critical as levels of pro-inflammatory cytokines are increased and the immune system is dysregulated. Other contributors to AN pathogenesis have been proposed, such as increased oxidative stress, dysbiosis of the gut microbiota and altered metabolomic profiles. Treatment options for patients with AN constitutes outpatient and inpatient care accordingly with the severity of the disorder. So far, no biomarker has been strongly proposed as an indicator of the disorder's severity or for assessing the progression of the treatment. The purpose of this study is to assess and monitor the nutritional rehabilitation of patients with AN during hospitalization treatment. Throughout the treatment's course, nutrition and feeding process, vital signs, psychopathology and biological samples will be gathered and statistical analysis of these data is expected to reveal potential biomarker/s for monitoring the progression of recovery.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | January 30, 2025 |
Est. primary completion date | January 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: • Patients with Anorexia Nervosa according to the DSM-V (American Psychiatric Association, 2013) Exclusion criteria: • Antibiotic treatment before and during the study |
Country | Name | City | State |
---|---|---|---|
Greece | Kaliora, Andriana C. | Athens | Attica |
Lead Sponsor | Collaborator |
---|---|
Harokopio University | Attiko Hospital, National and Kapodistrian University of Athens (NKUA) Medical School, Eginitio Hospital, National and Kapodistrian University of Athens (NKUA) Medical School, Institute of Chemical Biology National Hellenic Research Foundation, Sismanoglio General Hospital |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Metabolic recovery in patients with AN | Changes in metabolite concentrations in gut microbiome. The changes will be evaluated via Nuclear Magnetic Resonance (NMR) metabolomics analysis in stool samples collected in different time intervals during in-hospital rehabilitation. | Day 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 |
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