Effects of Probiotics on gut microbiota changes in Children with Attention Deficit/hyperactivity disorder: a double-blind, randomized, placebo-controlled trial

Effects of Probiotics on Gut Microbiota Changes in Children with Attention Deficit/Hyperactivity Disorder (PROCAD): a double-blind, randomized, placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210211003

Enrollment

Registered

2021-02-11

Start date

2021-03-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Gut dysbiosis and ADHD symptoms in children with ADHD Gastrointestinal Microbiome Probiotics Attention Deficit Disorder with Hyperactivity

Interventions

The probiotic-containing dietary supplement will be orally administered 5 drops daily for 12 weeks. ,The placebo supplement will be an identical bottle containing sunflower oil solution. It will be or

Experimental Dietary Supplement,Placebo Comparator Other

Lactobacillus reuteri,Placebo group

Eligibility

Sex/Gender

All

Age

5 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Children fulfilled with DSM-5 criteria for ADHD and healthy children for control group, 2. Participant legally acceptable representative has provided written informed consent to study participation

Exclusion criteria

Exclusion criteria: 1. Had a known neurodevelopmental disorders example for autistic spectrum disorder, global developmental delay, 2. Had a known chronic disorder requiring long term medication including cancers, autoimmune disorders, metabolic disorders or chronic neurological disorders including epilepsy, 3.History of received stimulant, sedative, antipsychotic, beta-blocker, calcium channel-blocker medications within 14 days prior to screening, 4.History of received oral antibiotics within 14 days prior to screening, 5. History of received prebiotics or probiotics within 14 days prior to screening, 6. Participants has a documented allergy, hypersensitivity, or intolerance to any of the ingredients of the intervention, 7 .Selective eating such as vegan, vegetarian

Design outcomes

Primary

Measure	Time frame
Gut microbiota at allocation time, at 1, 2, 3 month, and at 1 month after intervention Quantitative Polymerase Chain Reaction (qPCR)	—

Secondary

Measure	Time frame
Symptoms of ADHD at allocation time, at 1, 2, 3 month, and at 1 month after intervention SNAP-IV, CGI-IS, CGI-I, PedsQL, SDQ, CSHQ	—

Countries

Thailand

Contacts

Public ContactNonglak Boonchooduang

Faculty of Medicine, Chiang Mai University

Nonglak.b@cmu.ac.th0861792129

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026