Treatment of ADHD with synbiotics (probiotics plus prebiotics)
Not Applicable
Completed
- Conditions
- Attention-deficit hyperactivity disorderDisturbance of activity and attentionMental and Behavioural Disorders
- Registration Number
- ISRCTN57795429
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32497779/ results (added 26/10/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36904292/ (added 14/06/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 182
Inclusion Criteria
1. ADHD diagnosis
2. Swedish speaker
3. Aged 5-55 years old
Exclusion Criteria
1. Autism diagnosis
2. Gastrointestinal diagnosis other than IBS
3. Diabetes
4. Antibiotic drug treatment last six weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Symptoms of inattention, hyperactivity/impulsivity is measured using ASRS for adults and SNAP-IV for children at baseline and 12 weeks.<br>2. Symptoms of autism is measured using AQ for adults and SCQ for children at baseline and 12 weeks. <br>3. Function is measured using WFIRS at baseline and 12 weeks.
- Secondary Outcome Measures
Name Time Method 1. Emotional regulation is measured in adults using DERS-16 at baseline and 12 weeks.<br>2. Insomnia is measured using KSQ for adults and ISI for children at baseline and 12 weeks.<br>3. Well-being is measured in adults using the well-being scale at baseline and 12 weeks.<br>4. Gastrointestional symptoms is measured using the Bristol Stool Scale and one pain question at baseline and 12 weeks.<br>5. Plasma immune activity markers is measured using multiplex immunoassays at baseline and 12 weeks.<br>6. Plasma bacterial metabolites e.g. short chain fatty acids is measured using LC-MS/MS at baseline and 12 weeks.<br>7. Feces microbiome is measured using shot gun sequencing at baseline and 12 weeks.