Treatment of ADHD with synbiotics (probiotics plus prebiotics)

Randomized placebo-controlled trial in children and adults with ADHD of the effect of Synbiotic2000Forte on symptoms and function.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN57795429

Enrollment

248

Registered

2019-05-02

Start date

2016-01-10

Completion date

Unknown

Last updated

2025-03-17

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

Conditions

Attention-deficit hyperactivity disorder Mental and Behavioural Disorders Disturbance of activity and attention

Interventions

Synbiotic2000 or placebo, 1 bag daily, 9 weeks treatment, follow-up for both treatments. Randomisation by external in blocks of 10 by external unit. Active treatment: Synbiotic being is a composition

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. ADHD diagnosis 2. Swedish speaker 3. Aged 5-55 years old

Exclusion criteria

Exclusion criteria: 1. Autism diagnosis 2. Gastrointestinal diagnosis other than IBS 3. Diabetes 4. Antibiotic drug treatment last six weeks

Design outcomes

Primary

Measure	Time frame
1. Symptoms of inattention, hyperactivity/impulsivity is measured using ASRS for adults and SNAP-IV for children at baseline and 12 weeks. 2. Symptoms of autism is measured using AQ for adults and SCQ for children at baseline and 12 weeks. 3. Function is measured using WFIRS at baseline and 12 weeks.	—

Secondary

Measure	Time frame
1. Emotional regulation is measured in adults using DERS-16 at baseline and 12 weeks. 2. Insomnia is measured using KSQ for adults and ISI for children at baseline and 12 weeks. 3. Well-being is measured in adults using the well-being scale at baseline and 12 weeks. 4. Gastrointestional symptoms is measured using the Bristol Stool Scale and one pain question at baseline and 12 weeks. 5. Plasma immune activity markers is measured using multiplex immunoassays at baseline and 12 weeks. 6. Plasma bacterial metabolites e.g. short chain fatty acids is measured using LC-MS/MS at baseline and 12 weeks. 7. Feces microbiome is measured using shot gun sequencing at baseline and 12 weeks.	—

Measure

Time frame

1. Emotional regulation is measured in adults using DERS-16 at baseline and 12 weeks. 2. Insomnia is measured using KSQ for adults and ISI for children at baseline and 12 weeks. 3. Well-being is measured in adults using the well-being scale at baseline and 12 weeks. 4. Gastrointestional symptoms is measured using the Bristol Stool Scale and one pain question at baseline and 12 weeks. 5. Plasma immune activity markers is measured using multiplex immunoassays at baseline and 12 weeks. 6. Plasma bacterial metabolites e.g. short chain fatty acids is measured using LC-MS/MS at baseline and 12 weeks. 7. Feces microbiome is measured using shot gun sequencing at baseline and 12 weeks.

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Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026