Assessment of Probiotics Lactobacillus in the Management of Attention Deficit Hyperactive Disorder (ADHD)

Ain Shams University

Status and phase: Completed; Early Phase 1

Conditions: Hyperactivity; Inattentive; Impulsivity

Treatments: Drug: Probiotic Formula lacteal forte

Study type: Interventional

Funder types: Other

Identifiers

NCT04167995

FWA 000017

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Patient with attention deficit hyperactive disorser

Active Comparator group

Description:

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

Treatment:

Drug: Probiotic Formula lacteal forte

ADHD not receiving probiotics

No Intervention group

Description:

ADHD patient (40) on standard treatment