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

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

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

Study Overview

• Status: Completed
• Conditions: Hyperactivity; Impulsivity; Inattentive
• Intervention / Treatment: Drug: Probiotic Formula lacteal forte

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Reham Ibrahim; Phone Number: 01013636862; Email: rehamibrahim83@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt, 11757
    • Reham Ibrahim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patient with attention deficit hyperactive disorser; 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; 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
No Intervention: ADHD not receiving probiotics; ADHD patient (40) on standard treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Reham Ibrahim, Ain shams university

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2020
• Primary Completion (Actual): November 9, 2020
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Probiotics; Hyperactivity; Inattention
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Hyperkinesis; Impulsive Behavior
• Other Study ID Numbers: FWA 000017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No