Actively Recruiting

Age: 16Years - 50Years
FEMALE
NCT06144905

Norwegian Microbiota Study in Anorexia Nervosa

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

180

Participants Needed

1

Research Sites

1040 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

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

Official Title

Norwegian Microbiota Study in Anorexia Nervosa

Who Can Participate

Age: 16Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female sex
  • Age between 16 and 50 years
  • Body mass index (BMI) less than 18.5 kg/m2
  • Diagnosis meeting ICD-10 criteria for anorexia nervosa
  • Currently referred to specialized inpatient nutritional treatment for anorexia nervosa
  • Ability to understand Norwegian questionnaires
Not Eligible

You will not qualify if you...

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

AI-Screening

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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

CONTACT

Ø

Øyvind Rø, PhD

CONTACT

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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