The Norwegian Microbiota Study in Anorexia Nervosa (NORMA): Integrating a clinical trial with preclinical experiments-A study protocol
Abstract
Background: Anorexia nervosa (AN) remains difficult to treat, partly due to co-occurring mental health challenges and gastrointestinal symptoms. Emerging research suggests that individuals with AN exhibit gut microbiota dysbiosis and dysregulation in the gut-brain axis (GBA). However, research examining the role of gut microbiota as a potential driver of AN-related pathologies remains limited. The Norwegian Microbiota Study in Anorexia Nervosa (NORMA) will therefore investigate gut microbiota and its interaction with the GBA in AN.
Methods: NORMA is a collaboration between the Norwegian University of Life Sciences and seven Norwegian specialized eating disorder inpatient treatment units, consisting of three work packages (WP): a clinical observational trial (WP1), in vitro fermentation experiments (WP2), and animal experiments (WP3). In WP1, 90 patients with AN (age 16-50, BMI < 18.5) admitted for treatment and 90 healthy controls (HCs, age 16-50, BMI 18.5-27) will be recruited. Data on mental and physical health, dietary intake, and blood and fecal samples for biomarker and microbiota analyses will be collected at baseline, 6 and 12 weeks after start of treatment for AN patients and once for HCs. Outcomes will be compared between groups, and longitudinal effects of standard treatment examined within the AN group. In WP2, fecal microorganisms from patients and HCs will be grown in vitro to assess influence of prebiotics. In WP3, mice will receive fecal microbiota from AN and…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 90 participants or records.
Read the paper
Related studies
- The Matrisome: In Silico Definition and In Vivo Characterization by Proteomics of Normal and Tumor Extracellular Matrices
- The Escherichia coli MG1655 in silico metabolic genotype: Its definition, characteristics, and capabilities
- In silico pharmacology for drug discovery: methods for virtual ligand screening and profiling
- In silico prediction of splice-altering single nucleotide variants in the human genome
- In silico clinical trials: how computer simulation will transform the biomedical industry
- In silico optimization of a guava antimicrobial peptide enables combinatorial exploration for peptide design
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.