To study the differences in MI between short-term ill adolescents with AN (< illness duration 1 year) and patients who started their illness in adolescence and have been ill for at least 5 years consecutively and with healthy controls. A…
ID
Source
Brief title
Condition
- Eating disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: Differences in MI between short-term ill and long-term ill
patients and HC, cross-sectional and longitudinally during weight restoration
over 1 year.
Secondary outcome
Secondary outcomes: Changes in MI composition in relation to olanzapine use,
locomotor activity, gastrointestinal complaints, eating disorder symptoms,
anxiety, mood, neuropsychological inefficiencies, gut permeability, serum
inflammation markers, IgG analysis.
Background summary
Anorexia nervosa (AN) is one of the most serious chronic disorders of youth. Up
to now we only know moderately effective treatment strategies; less than 50% of
affected patients fully recover. Recently, there has been an emerging evidence
of an association between the bacteria living in the human gut (gut microbiome
(MI)) and the brain; several studies demonstrated that the composition of the
microbiome and its metabolism have an important influence on the development of
mental disorders and on weight regulation disorders such as obesity. In AN,
fasting (*starvation*) induces severe perturbations of the gut microbiome,
which do not alleviate with weight gain. Animal models elucidate that the
microbiome influences body weight, brain development and depression-like
states. Thus, our aim is to improve the course of this disabling disorder by
manipulating the patients* gut bacteria. We hypothesize that changes of the
microbiome of chronically ill patients are more profound than those of patients
with a short duration of AN, and differ from controls and that the composition
of the microbiome is associated with neuropsychological functioning
Study objective
To study the differences in MI between short-term ill adolescents with AN (<
illness duration 1 year) and patients who started their illness in adolescence
and have been ill for at least 5 years consecutively and with healthy controls.
A secondary objective is to relate the composition of the microbiome to
physiological (hormone levels, hyperactivity) and psychological (cognitive
flexibility) characteristics.
Study design
Our work plan comprises an observational longitudinal study by which we want to
compare the microbiome of patients with a short duration of illness with the
microbiome of those who are chronically ill and with healthy controls on three
time points: at start treatment, after 6 months and after 1 year.
Study burden and risks
Patients will be assessed three times, controls twice. On each occasion
participants fill in questionnaires and perform computer tasks, provide a stool
and blood sample, and wear an Actiwatch for 2 days. The risk is considered low
in this study considering the observational nature of the study.
Universiteitsweg 100
Utrecht 3584CG
NL
Universiteitsweg 100
Utrecht 3584CG
NL
Listed location countries
Age
Inclusion criteria
Female patients between 13 and 20 years of age (first-time ill) for the first
group, and between 18 and 35 years of age (start in adolescence) with AN and
atypical AN according to DSM-5 for the second (chronic) patients.
Age-matched controls without eating disorder, BMI < 80th percentile and > 20th
percentile.
Exclusion criteria
Organic brain disease, psychotic disorder, bipolar disorder, IQ < 80,
insufficient knowledge of Dutch language, antibiotic use during the previous 6
weeks, substance abuse, pregnancy, diabetes, or gastrointestinal diseases.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70832.041.19 |
| Other | NL8566 |