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Completed

NCT Number: NCT04167995

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

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

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Key information

Conditions

Inattentive Behavior Hyperactivity Impulsive Behavior Impulsivity Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Reham Ibrahim

Cairo, 11757, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic Formula lacteal forte

Drug

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 .

Other names: Lacteal forte

Primary outcomes

  1. Conner's Parent Rating Scales-Revised (CRS-R):for follow up

    Time frame: 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

  2. Child behavior checklist

    Time frame: 3 months

    Parent form to asses the associated internalizing and externalizing behaviour

Secondary outcomes

  1. Conners Continuous Performance Test (CPT)

    Time frame: 3 months

    To asses sustained attention and impulsivity

  2. Wisconsin (Berg) Card Sort Test (WCST)

    Time frame: 3 months

    To evaluate executive function

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Acronym: ADHD

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Nov 19, 2019
Registry last updated
Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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