NCT02962726

Brief Summary

The aim of this study is to evaluate the effect of starvation and recovery in adolescent anorexia nervosa patients in regard to microbiome activity and composition and to elucidate potential connections between weight gain, depression and other comorbidities, further to capture hormone levels and inflammation parameters in a longitudinal design.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

2.9 years

First QC Date

November 9, 2016

Last Update Submit

October 25, 2022

Conditions

Anorexia Nervosa

Keywords

AnorexiaDepressionMicrobiome

Outcome Measures

Primary Outcomes (1)

  • Correlation BMI and Microbiome Variability

    Correlation between Body Mass Index and Microbiome Variability.

    12 month

Secondary Outcomes (4)

  • Bacteria

    12 month

  • Bacteria activity

    12 month

  • Inflammatory parameters

    12 month

  • Depression

    12 month

Study Arms (2)

Patients

100 female patients between the age of 12 and 18 years suffering from anorexia nervosa.

Age matched Controls

100 females volunteers between the age of 12 and 18 years old without eating disorder.

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

100 female patients suffering from anorexia nervosa. 100 female volunteers without eating or mental disorder.

You may qualify if:

  • Written informed consent by Patient/volunteer and caregiver.
  • Volunteers with BMI between 10 and 90 percentile of their age group.
  • Volunteers without prior eating or mental disorder.

You may not qualify if:

  • Psychotic disorder(s)
  • Personality disorder(s)
  • Alcohol and substance abuse
  • Prone to self-harming behaviour
  • Primary caregiver insufficient German language skills
  • Patient/Volunteers IQ lower 85

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Paediatric Psychiatry, Psychosomatic Disorders and Psychotherapy

Aachen, North Rhine Westphali, 52074, Germany

Location

Related Publications (5)

  • Herpertz-Dahlmann B. Adolescent eating disorders: update on definitions, symptomatology, epidemiology, and comorbidity. Child Adolesc Psychiatr Clin N Am. 2015 Jan;24(1):177-96. doi: 10.1016/j.chc.2014.08.003. Epub 2014 Oct 7.

    PMID: 25455581BACKGROUND

  • Raevuori A, Haukka J, Vaarala O, Suvisaari JM, Gissler M, Grainger M, Linna MS, Suokas JT. The increased risk for autoimmune diseases in patients with eating disorders. PLoS One. 2014 Aug 22;9(8):e104845. doi: 10.1371/journal.pone.0104845. eCollection 2014.

    PMID: 25147950BACKGROUND

  • Solmi M, Veronese N, Favaro A, Santonastaso P, Manzato E, Sergi G, Correll CU. Inflammatory cytokines and anorexia nervosa: A meta-analysis of cross-sectional and longitudinal studies. Psychoneuroendocrinology. 2015 Jan;51:237-52. doi: 10.1016/j.psyneuen.2014.09.031. Epub 2014 Oct 8.

    PMID: 25462897BACKGROUND

  • Corcos M, Guilbaud O, Paterniti S, Moussa M, Chambry J, Chaouat G, Consoli SM, Jeammet P. Involvement of cytokines in eating disorders: a critical review of the human literature. Psychoneuroendocrinology. 2003 Apr;28(3):229-49. doi: 10.1016/s0306-4530(02)00021-5.

    PMID: 12573293BACKGROUND

  • Tennoune N, Legrand R, Ouelaa W, Breton J, Lucas N, Bole-Feysot C, do Rego JC, Dechelotte P, Fetissov SO. Sex-related effects of nutritional supplementation of Escherichia coli: relevance to eating disorders. Nutrition. 2015 Mar;31(3):498-507. doi: 10.1016/j.nut.2014.11.003. Epub 2014 Dec 5.

    PMID: 25701341BACKGROUND

MeSH Terms

Conditions

Anorexia NervosaAnorexiaDepression

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Jochen Seitz, MD

    University Hospital, Aachen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 11, 2016

Study Start

September 1, 2016

Primary Completion

August 1, 2019

Study Completion

September 1, 2019

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)