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NCT05627583
Nutritional Rehabilitation and Markers of Severity in Anorexia Nervosa
Conditions: Anorexia Nervosa
Sex: All
Ages: 18 Years – N/A
Enrollment: 20
Sponsor: Harokopio University
Location: Greece
Summary
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.
Eligibility Criteria
Inclusion Criteria:• Patients with Anorexia Nervosa according to the DSM-V (American Psychiatric Association, 2013)Exclusion criteria:• Antibiotic treatment before and during the study
Source: ClinicalTrials.gov (NCT05627583). StuddyBuddy aggregates publicly available trial information.