Norwegian Microbiota Study in Anorexia Nervosa

NCT ID: NCT06144905

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-24
• Study Completion Date: 2043-09-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Anorexia nervosa (AN) group

Female in-patients with anorexia nervosa, age 16-50 years with BMI below 18.5 kg/m2.

standard care treatment program

Intervention Type: OTHER

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

Heathy control (HC) group

Female healthy controls, age 16-50 with normal to mild overweight (18.5 ≤ BMI\< 27 kg/m2). .

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Sex: Female

2. Age: 16-50 years

3. BMI: <18.5 kg/m2

4. fulfilling ICD-10 criteria for AN

5. currently referred to specialized inpatient nutritional treatment for AN

6. able to understand the Norwegian questionnaires.

1. Sex: Female

2. Age: 16-50 years

3. BMI: >= 18.5 & < 27

4. able to understand the Norwegian questionnaires.

Exclusion Criteria

1. history of inflammatory bowel disease, celiac disease, or GI tract surgery;

2. treatment with oral antibiotics the past two months

3. high intake of probiotic supplements over the past two months.

1. history of inflammatory bowel disease, celiac disease, or GI tract surgery;

2. treatment with oral antibiotics the past two months

3. high intake of probiotic supplements over the past two months.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

Nordlandssykehuset HF

OTHER

Sponsor Role: collaborator

Modum Bad

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

The Eating disorder Association, Norway (SPISFO)

UNKNOWN

Sponsor Role: collaborator

Counseling on eating disorders, Norway (ROS)

UNKNOWN

Sponsor Role: collaborator

Norwegian University of Life Sciences

OTHER

Sponsor Role: lead

Responsible Party

Siv K Bohn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siv K Bøhn, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Life Sciences

Locations

Norwegian University of Life Sciences

Ås, Ås, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Siv K Bøhn, PhD

Role: CONTACT

sivb@nmbu.no

+47 67232502

Øyvind Rø, PhD

Role: CONTACT

oeyvro@ous-hf.no

+47 23016230

Facility Contacts

Siv Kjølsrud Bøhn, PhD

Role: primary

sivb@nmbu.no

Ida Heir Hovland, MSc

Role: backup

ida.heir.hovland@nmbu.no

Other Identifiers

336239_KBM_SKB2023

Identifier Type: -

Identifier Source: org_study_id