The Norwegian Microbiota Study in Anorexia Nervosa (NORMA): Integrating a clinical trial with preclinical experiments-A study protocol.
Ida Heir Hovland, Lasse Bang, Anne Mari Herfindal...
https://pubmed.ncbi.nlm.nih.gov/41811825Actively Recruiting
Led by Norwegian University of Life Sciences · Updated on 2025-05-23
180
Participants Needed
1
Research Sites
939 weeks
Total Duration
N
Norwegian University of Life Sciences
Lead Sponsor
O
Oslo University Hospital
Collaborating Sponsor
Researchers are investigating the role of gut microbiota in anorexia nervosa (AN), a serious mental disorder mostly affecting women and characterized by severely restricted food intake and low body weight. This condition often leads to medical complications and psychiatric issues, with current treatments linked to gastrointestinal problems and high relapse rates. The study aims to better understand how gut microbes are affected by standard care treatment and explore the potential of prebiotics as a new approach to improve health and weight restoration in AN patients. The study includes female participants aged 16 to 50 years divided into two groups: those with AN and healthy controls with normal to mild overweight BMI ranges. The AN group will undergo a standard care treatment program involving psychotherapy and nutritional rehabilitation to normalize food intake and promote weight gain. Samples and data are collected at baseline before starting clinical treatment, and again at approximately 6 and 12 weeks during treatment. Healthy controls provide data at one time point only. Participants will have their fecal microbiota composition studied alongside assessments of mental health and gastrointestinal symptoms at multiple time points. Researchers will analyze associations between microbiota diversity, serum biomarkers, diet, and clinical symptoms. The study monitors changes during the treatment period to understand microbiota dynamics and their relation to mental and gastrointestinal health. The study is expected to continue until 2043, aiming to pave the way for personalized prebiotic treatments for AN.
CONDITIONS
Norwegian Microbiota Study in Anorexia Nervosa
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants with anorexia nervosa provide fecal samples and complete questionnaires during the standard care treatment program to observe changes in gut microbiota, mental health, and gastrointestinal symptoms.
3 visits (baseline, ~6 weeks, and ~12 weeks)
Total: 1 location
1
Norwegian University of Life Sciences
Ås, Ås, Norway, 1433
Actively Recruiting
S
Siv K Bøhn, PhD
Ø
Øyvind Rø, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Ida Heir Hovland, Lasse Bang, Anne Mari Herfindal...
https://pubmed.ncbi.nlm.nih.gov/41811825