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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Inattentive, Hyperactivity, Impulsivity

Intervention / Treatment
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* Drug: Probiotic Formula lacteal forte


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient with attention deficit hyperactive disorser<br>patients (n=40) will receive 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 standard treatment | Drug: Probiotic Formula lacteal forte<br>* Active Comparator: Patient with attention deficit hyperactive disorder patients (n=40) will receive 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 .<br>* Other names: Lacteal forte;|
| No Intervention: ADHD not receiving probiotics<br>ADHD patient (40) on standard treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conner's Parent Rating Scales-Revised (CRS-R):for follow up | This tool is used in order to assess the profile and severity of symptoms, response to treatment and follow up studies. Items are scored on 14 subscales of symptoms including opposition, cognitive problems, inattention, and hyperactivity.It is usually considered normal when T-scores are less than 60, while scores above 60 are signs of academic, behavioral, or social issues. There are several different classes as well | 3 months | 
| Child behavior checklist | Parent form to asses the associated internalizing and externalizing behaviour | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conners Continuous Performance Test (CPT) | To asses sustained attention and impulsivity | 3 months | 
| Wisconsin (Berg) Card Sort Test (WCST) | To evaluate executive function | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperactivity, Inattention, Probiotics