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

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 - TRACEBIOME: an exploratory investigation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42519

Enrollment

301

Registered

2015-12-29

Start date

2016-05-31

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD attention-deficit/hyperactivity disorder

Interventions

See TRACE (2014-1349): -Elimination diet -Control diet -Care as usual

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
In summary the following measures related to the microbiome-gut-brain axis will be obtained: * Microbiome quantity and composition * Concentrations of shortchained fatty acids * (Stress) Hormone levels, such as cortisol * Immunoprofiling, such as concentration of proinflammatory cytokin and immunoglobulin * Genotype (DNA/RNA)	—

Secondary

Measure	Time frame
Controlvariables assessed for TRACE, such as demographics (age, sex)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)