drugset / Trial / NCT04167995

Assessment of Probiotics Lactobacillus in the Management of Attention Deficit Hyperactive Disorder

NCT04167995 ↗

Phase 0 Completed 80 enrolled Ain Shams University
RandomizedParallel-groupDouble-blindTreatment

Summary

ADHD is a neurodevelopmental disorder characterized by persistent symptoms of inattention and/or hyperactivity and impulsivity that are present before age 18. These symptoms must be evident across ADHD treatment is currently based on a multimodal approach with the combination of psychotherapy and pharmacotherapy, but no reliable markers of treatment response have been identified yet and 20-35% of subjects in clinical trials may have an inadequate response to the treatment The gut microbiome refers to the microbial ecosystem found in the gastrointestinal system of the human species Probiotics are a type of beneficial bacteria that improve health and facilitate intestinal microbial balance Increasing evidence suggests that the gut microbiota plays a key role in the gut-brain communication axis by influencing metabolism, inflammation, the hypothalamic-pituitary-adrenal axis, and neurotransmission multiple domains and cause Impairment in functioning in order to meet the diagnostic criteria for ADHD

Timeline

Start
2020-06-09
Primary completion
2020-11-09
Completion
2021-10-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lactobacillus acidophilus LB Unknown 1e+10 unknown —