Actively Recruiting

Age: 16Years - 50Years
FEMALE
ID06144905

Gut Microbiota Alterations in Anorexia Nervosa - Paving the Way for Personalized Prebiotic Treatment Strategies

Led by Norwegian University of Life Sciences · Updated on 2025-05-23

180

Participants Needed

1

Research Sites

939 weeks

Total Duration

On this page

Sponsors

N

Norwegian University of Life Sciences

Lead Sponsor

O

Oslo University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Norwegian Microbiota Study in Anorexia Nervosa

Who Can Participate

Age: 16Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants
  • Age between 16 and 50 years
  • For AN group: BMI below 18.5 kg/m2
  • For AN group: meeting ICD-10 criteria for anorexia nervosa
  • For AN group: currently referred for specialized inpatient nutritional treatment
  • Ability to understand Norwegian questionnaires
  • For control group: BMI between 18.5 and less than 27 kg/m2
Not Eligible

You will not qualify if you...

  • History of inflammatory bowel disease, celiac disease, or gastrointestinal tract surgery
  • Treatment with oral antibiotics in the past two months
  • High intake of probiotic supplements in the past two months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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)

Trial Site Locations

Total: 1 location

1

Norwegian University of Life Sciences

Ås, Ås, Norway, 1433

Actively Recruiting

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Research Team

S

Siv K Bøhn, PhD

Ø

Øyvind Rø, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

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/41811825