Microbiome Shifts in Adolescent Anorexia Nervosa (MaAN)
October 25, 2022 updated by: RWTH Aachen University
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Rhine Westphali
-
Aachen, North Rhine Westphali, Germany, 52074
- Clinic for Paediatric Psychiatry, Psychosomatic Disorders and Psychotherapy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
100 female patients suffering from anorexia nervosa.
100 female volunteers without eating or mental disorder.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation BMI and Microbiome Variability
Time Frame: 12 month
|
Correlation between Body Mass Index and Microbiome Variability.
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bacteria
Time Frame: 12 month
|
Qualitative description of bacteria species
|
12 month
|
|
Bacteria activity
Time Frame: 12 month
|
Quantitative description of Bacterial activity
|
12 month
|
|
Inflammatory parameters
Time Frame: 12 month
|
12 month
|
|
|
Depression
Time Frame: 12 month
|
Depression assessment Beck's Depression Inventory II
|
12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jochen Seitz, MD, University Hospital RWTH Aachen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
August 1, 2019
Study Completion (Actual)
September 1, 2019
Study Registration Dates
First Submitted
November 9, 2016
First Submitted That Met QC Criteria
November 10, 2016
First Posted (Estimate)
November 11, 2016
Study Record Updates
Last Update Posted (Actual)
October 26, 2022
Last Update Submitted That Met QC Criteria
October 25, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-093
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.