Anorexia NervosaMaANNCT02962726
Microbiome Shifts in Adolescent Anorexia Nervosa
An observational study of Anorexia Nervosa, run by RWTH Aachen University at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2016to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: 100 female patients suffering from anorexia nervosa. 100 female volunteers without eating or mental disorder.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for Paediatric Psychiatry, Psychosomatic Disorders and Psychotherapy
Aachen, North Rhine Westphali, 52074
About this study
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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia, Depression, Microbiome
- Medical subject headings
- Anorexia Nervosa, Anorexia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Correlation BMI and Microbiome Variability
Correlation between Body Mass Index and Microbiome Variability.
Measured: 12 month
Secondary outcomes (4)
Bacteria
Qualitative description of bacteria species
Measured: 12 month
Bacteria activity
Quantitative description of Bacterial activity
Measured: 12 month
Inflammatory parameters
Measured: 12 month
Depression
Depression assessment Beck's Depression Inventory II
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start1 Sep 2016
- Primary completion1 Aug 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jochen Seitz, MD, Principal investigator, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962726
- Sponsor's protocol ID
- 16-093
- Acronym
- MaAN
- Status last verified
- Oct 2022
- First submitted
- 9 Nov 2016
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 25455581Raevuori 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.
PubMed 25147950Solmi 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.
PubMed 25462897Corcos 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.
PubMed 12573293Tennoune 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.
PubMed 25701341
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome Shifts in Adolescent Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT02962726
- Acronym / sponsor ID
- MaAN / 16-093
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia, Depression, Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 100 female patients suffering from anorexia nervosa. 100 female volunteers without eating or mental disorder.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Psychotic disorder(s)
- Personality disorder(s)
- Alcohol and substance abuse
- Prone to self-harming behaviour
- Primary caregiver insufficient German language skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation BMI and Microbiome Variability
Time frame: 12 month
Correlation between Body Mass Index and Microbiome Variability.
4 secondary outcomes
Bacteria
Time frame: 12 month
Bacteria activity
Time frame: 12 month
Inflammatory parameters
Time frame: 12 month
Depression
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Background: PubMed 25455581Herpertz-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.
- Background: PubMed 25147950Raevuori 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.
- Background: PubMed 25462897Solmi 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.
- Background: PubMed 12573293Corcos 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.
- Background: PubMed 25701341Tennoune 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen Seitz, MD principal investigator
University Hospital, Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation BMI and Microbiome Variability (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02962726, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.