Microbiome Shifts in Adolescent Anorexia Nervosa (MaAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02962726
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : November 15, 2016
Information provided by (Responsible Party):
RWTH Aachen University

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.

Condition or disease
Anorexia Nervosa

Detailed Description:
Anorexia Nervosa (AN) has the highest mortality of all psychiatric disorders. Large part of all patients the disorder becomes chronical. Until now, no (bio-) markers which allow a prognosis of outcome are known. Recently the function of the intestinal microbiome and its effects on food uptake, immunological processes and barrier malfunctions in the intestine is discussed. Especially the concept of the "leaky gut", an adsorption malfunction of the intestinal wall under starvation for antigens may help to explain the low inflammatory response which is commonly found in Anorexia Nervosa subjects and a connection to higher rate of autoimmune diseases by Anorexia Nervosa. Furthermore the presence and quantity of specific bacteria in the intestine seems to be dependent on patient's sex which would contribute to the gender gap of prevalence for Anorexia Nervosa. Stress induced changes of the HPA-axis which are well documented in Anorexia Nervosa patients and often persist even after weight rehabilitation, play an important part for intestinal wall permeability disorders. In the most often used animal model for AN, the Activity-Based Anorexia (ABA) model which combines nutrition restriction and weight loss with hyper activity, a malfunction in intestinal wall permeability was found. Malnutrition and long lasting dieting have a fast and reproducible impact on the intestinal microbiome. Especially animal derived food seems to support proliferation of pro-inflammatory bacteria. A substantial intestinal dysbiosis (reduced alpha-diversity) was found in AN patients which only partly recovered after weight rehabilitation. Reduction in diversity and composition of the microbiome was significantly associated with severity of depressive symptoms in patient, where severity is an indicator for higher level eating pathologies and poorer prognosis. Aim of this longitudinal study is therefore to investigate to interconnections between fecal microbiome and progression of AN, including associations with stress, inflammatory markers and metabolic markers in blood sera as well as clinical parameters such as severity of depression and eating pathologies.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Microbiome Shifts in Adolescent Anorexia Nervosa
Study Start Date : September 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

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.

Primary Outcome Measures :
  1. Correlation BMI and Microbiome Variability [ Time Frame: 12 month ]
    Correlation between Body Mass Index and Microbiome Variability.

Secondary Outcome Measures :
  1. Bacteria [ Time Frame: 12 month ]
    Qualitative description of bacteria species

  2. Bacteria activity [ Time Frame: 12 month ]
    Quantitative description of Bacterial activity

  3. Inflammatory parameters [ Time Frame: 12 month ]
  4. Depression [ Time Frame: 12 month ]
    Depression assessment Beck's Depression Inventory II

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
100 female patients suffering from anorexia nervosa. 100 female volunteers without eating or mental disorder.

Inclusion Criteria:

  • Female patients and volunteers between age 12 and 18 at inclusion.
  • 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.

Exclusion Criteria:

  • 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
  • Antibiotic treatment within 4 weeks prior to inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02962726

Contact: Jochen Seitz, MD +49 241 8089171
Contact: Beate Herpertz-Dahlmann, Prof. +49 241 8088737

Clinic for Paediatric Psychiatry, Psychosomatic Disorders and Psychotherapy Recruiting
Aachen, North Rhine Westphali, Germany, 52074
Contact: Jochen Seitz, MD    +49 241 8089171   
Contact: Beate Herpertz-Dahlmann, Prof    +49 241 8088737   
Sponsors and Collaborators
RWTH Aachen University
Principal Investigator: Jochen Seitz, MD University Hospital RWTH Aachen

Responsible Party: RWTH Aachen University Identifier: NCT02962726     History of Changes
Other Study ID Numbers: 16-093
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by RWTH Aachen University:

Additional relevant MeSH terms:
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders