Norwegian Microbiota Study in Anorexia Nervosa

NCT06144905 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2025-05-23

No results posted yet for this study

Summary

Anorexia nervosa (AN) is a serious mental disorder occurring mainly in women. AN is characterized by severely restricted food-intake and subsequent low weight. The disease burden for the individual is high with medical complications and psychiatric comorbidities. Despite decades of research, there are large gaps in the understanding of the biological aspects of AN and lack of effective interventions. Current clinical treatment is associated with gastrointestinal problems, high rates of relapse and poor outcome causing long-term sickness absence and disability. During the COVID19 pandemic the prevalence and severity of AN has spiked. Therefore, there is great need of novel strategies for AN treatment, that can be easily implemented in the clinic without adding complexity to the standard care of treatment. During the resent years it has been proposed that mental disorders might be treated via manipulating the composition and function of the microbes that live in the gut (the microbiota) by adding or restricting fermentable nutrients (prebiotics) in the diet. However, in order to use prebiotics to treat the microbiota in AN patients, more knowledge is needed on how the AN microbiota is affected by the current standard care treatment. Whether prebiotics can be useful for normalizing AN microbiota remains to be established. The overall aim of the "Norwegian study of Microbiota in Anorexia Nervosa" (NORMA) is to join forces of researchers, clinical health care services and voluntary sector in a transdiciplinary approach to improve the understanding of the role of the gut microbiota in AN patients. The current project will include a clinical trial in AN patients and experimental studies to screen novel prebiotics for their ability to modify and normalize AN derived microbiota. The long-term goal of the project is to pave the way for a targeted and clinically feasible individualized treatment for better tolerable weight-restoration and improved health in AN patients.

Conditions

  • Anorexia Nervosa
  • Mental Health Issue
  • Microbiota
  • Diet
  • Gastrointestinal Problems

Interventions

OTHER

standard care treatment program

The standard care treatment consists of a program of psychotherapy and nutritional rehabilitation to achieve normalization of food-intake and weight gain.

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER
  • Helse Nord-Trøndelag HF

    collaborator OTHER
  • Haukeland University Hospital

    collaborator OTHER
  • Nordlandssykehuset HF

    collaborator OTHER
  • Modum Bad

    collaborator OTHER
  • Karolinska Institutet

    collaborator OTHER
  • The Eating disorder Association, Norway (SPISFO)

    collaborator UNKNOWN
  • Counseling on eating disorders, Norway (ROS)

    collaborator UNKNOWN
  • Norwegian University of Life Sciences

    lead OTHER

Principal Investigators

  • Siv K Bøhn, PhD · Norwegian University of Life Sciences

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-24
Primary Completion
2025-09-30
Completion
2043-09-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06144905 on ClinicalTrials.gov