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Completed

NCT Number: NCT02962726

Microbiome Shifts in Adolescent Anorexia Nervosa

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.

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Key information

Age range

12 year–18 year

Sex eligibility

Female

Study type

Observational

Primary location

Clinic for Paediatric Psychiatry, Psychosomatic Disorders and Psychotherapy

Aachen, North Rhine Westphali, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation BMI and Microbiome Variability

    Time frame: 12 month

    Correlation between Body Mass Index and Microbiome Variability.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Acronym: MaAN

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 11, 2016
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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