Whole Gut Microbiome Sequencing in Patients With Anorexia Nervosa

NCT02217384 | Completed DMC

• 1 other identifier: S-20140040
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 3

Brief Summary

Background. Anorexia nervosa (AN) still carries the highest fatality rate of any psychiatric disease, and less than half of the patients recover, completely refractory to any treatment. The etiology remains unknown and evidence for treatment is lacking. The intestinal microbiota and its microbiome provide humans with additional gene products which may be regarded as an organ, which contributes to multiple host metabolic pathways. Recent advances in microbial DNA sequencing technologies have resulted in metagenomic DNA analysis of whole ecosystems such as the human gut. Altered intestinal microbiota has been related to obesity and insulin resistance. Hypothetically, the intestinal microbiota could play a role in the generation and/or maintenance of the emaciation in AN. Aim. The aim of the present study is to investigate whether gut microbiota is altered in patients with AN. Subjects and methods. A cross sectional study of the gut microbiome profiles in 75 clinical, psychometric and biochemical well characterized treatment seeking females with AN. The microbiome profiles are compared with 75 age- matched healthy Danish control subjects. Perspectives. Clarifying whether the intestinal flora is implicated in the susceptibility to or maintenance of AN may provide the basis for development of new highly required treatments.

Conditions

Anorexia Nervosa

Keywords

Microbiome; DNA sequencing; Leptin; Adiponectin; Insulin; IGF-I

Outcome Measures

Primary Outcomes (1)

• Diversity of faecal microbiota

  Metagenomic analyses of microbial DNA isolated from stool samples and sequenced applying a combination of deep and untargeted shotgun sequencing.

  Cross-sectional study with only one time point. The sample is delivered at a convenient time during an ongoing psychotherapeutic treatment.

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred to specialist unit.

You may qualify if:

• Women.
• Referred to specialized eating disorder center.
• Fulfill criteria in Diagnostic and Statistical Manual of Mental Disorders - 5.

You may not qualify if:

• Age \<15 years.
• Known ongoing abuse of laxatives.
• Antibiotic treatment within the last three months.
• Inflammatory bowel disease, colorectal cancer or other bowel disease.

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Copenhagen: collaborator
• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator
• INRA Research Center at Jouy-en-Josas: collaborator

Study Sites (3)

Unit for Psychiatric Research, Aalborg University Hospital.

Aalborg, 9000, Denmark

Location

Child and adolescent psychiatric unit. Risskov. Aarhus University Hospital.

Aarhus, 8000, Denmark

Location

Department of Endocrinology, Center for Eating Disorders. Odense University Hospital.

Odense, 5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gut microbiome Serum and plasma Cells (buffy coat) Urine

MeSH Terms

Conditions

Anorexia Nervosa; Insulin Resistance

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• René K Støving, PhD

  Center for Eating Disorders, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research secretary

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: August 15, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: April 1, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

DK (3)