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

Early Phase 1

Completed

• Conditions: Inattentive; Hyperactivity; Impulsivity
• Interventions: Drug: Probiotic Formula lacteal forte

• Registration Number: NCT04167995
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-19
• Study Start: 2020-06-09
• Primary Completion: 2020-11-09
• Study Completion: 2021-10-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-23
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient with attention deficit hyperactive disorser	Probiotic Formula lacteal forte	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

Primary Outcome Measures

Name	Time	Method
Conner's Parent Rating Scales-Revised (CRS-R):for follow up	3 months	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
Child behavior checklist	3 months	Parent form to asses the associated internalizing and externalizing behaviour

Secondary Outcome Measures

Name	Time	Method
Conners Continuous Performance Test (CPT)	3 months	To asses sustained attention and impulsivity
Wisconsin (Berg) Card Sort Test (WCST)	3 months	To evaluate executive function

Trial Locations

Locations (1)

Reham Ibrahim; 🇪🇬 Cairo, Egypt