Treatment of ADHD with Care as usual versus an Elimination diet: An exploratory investigation on the biological mechanisms underlying the effects of an elimination diet treatment in ADHD
Recruiting
- Conditions
- ADHDattention-deficit/hyperactivity disorder10009841
- Registration Number
- NL-OMON42519
- Lead Sponsor
- CNS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 301
Inclusion Criteria
Part of TRACE (20141349):
-clinical ADHD diagnosis according to DSM5 (any subtype)
-ADHD treatment abstinent in past two months
-5-12 years old
-ADHD Rating Scale score higher than 1.5 SD above the mean
-confirmed research diagnosis by a structured psychiatric interview with the parents (KSADS)
-comorbidities are allowed
Exclusion Criteria
Part of TRACE (20141349):
-children being treated for ADHD in the past two months (medication, therapy or diet)
-use of any other psychotropic edication
-children and/or parents with inadequate mastery of Dutch language
-eating disorder/diatebes
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In summary the following measures related to the microbiome-gut-brain axis will<br /><br>be obtained:<br /><br>* Microbiome quantity and composition<br /><br>* Concentrations of shortchained fatty acids<br /><br>* (Stress) Hormone levels, such as cortisol<br /><br>* Immunoprofiling, such as concentration of proinflammatory cytokin and<br /><br>immunoglobulin<br /><br>* Genotype (DNA/RNA)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Controlvariables assessed for TRACE, such as demographics (age, sex)</p><br>