Clinical trial NCT04167995: Assessment of Probiotics Lactobacillus in the Management of Attention Deficit Hyperactive Disorder
Official title: Assessment of Probiotic Strain Lactobacillus Acidophilus LB Supplementation as Adjunctive Management of Attention-deficit Hyperactivity Disorder in Children and Adolescents: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Inattentive
Hyperactivity
Impulsivity
Keywords: Hyperactivity
Inattention
Probiotics
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: All patients will be randomly distributed into two equal groups using a random number generator from computer-based randomization software. the probiotic group (n=40) received probiotic preparation twice daily (Lacteol Forte; Rameda, Egypt) as sachets containing 10 billion colony-forming units (CFU) of Lactobacillus fermentum and Lactobacillus delbruekii for 12 weeks added to a weight-dependent dose of standard treatment (Atomoxetine), and the 40 patients in the control group will not receive the probiotic and on a weight-dependent dose of atomoxetine.

Eligibility criteria: Inclusion Criteria:

* Age from 6 to 16 years old.
* Children fulfilled DSM(V) Criteria for ADHD syndrome.

Exclusion Criteria:

* Intelligence quotient (IQ) less than 80% .
* Presence of other medical conditions as chronic medical or neuropsychiatric disorders e.g diabetes mellitus, epilepsy.....etc. hearing or visual impairment, or medications side effects.
* currently taking probiotics or antibiotics

Primary outcomes:
measure: Conner's Parent Rating Scales-Revised (CRS-R):for follow up
timeFrame: 3 months
measure: Child behavior checklist
timeFrame: 3 months
Secondary outcomes:
measure: Conners Continuous Performance Test (CPT)
timeFrame: 3 months
measure: Wisconsin (Berg) Card Sort Test (WCST)
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Reham Ibrahim
Study officials:
affiliation: Ain Shams University
name: Reham Ibrahim
role: STUDY_DIRECTOR
References: