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

NCT04167995 | Completed Early Phase 1

• 1 other identifier: FWA 000017
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Inattentive; Hyperactivity; Impulsivity

Keywords

Hyperactivity; Inattention; Probiotics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Conners Continuous Performance Test (CPT)

  3 months

• Wisconsin (Berg) Card Sort Test (WCST)

  3 months

Study Arms (2)

Patient with attention deficit hyperactive disorser

ACTIVE COMPARATOR

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

ADHD not receiving probiotics

NO INTERVENTION

ADHD patient (40) on standard treatment

Interventions

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 .

Also known as: Lacteal forte

Patient with attention deficit hyperactive disorser

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Reham Ibrahim

Cairo, 11757, Egypt

Location

Related Publications (1)

• Elhossiny RM, Elshahawy HH, Mohamed HM, Abdelmageed RI. 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. BMC Psychiatry. 2023 Nov 9;23(1):823. doi: 10.1186/s12888-023-05324-4.

  PMID: 37946220 DERIVED

MeSH Terms

Conditions

Spasm; Impulsive Behavior

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Reham Ibrahim

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Using a computer-based randomization program. The allocation was concealed in sealed envelopes. Only the researchers collecting and analyzing the data were blinded to the study groups (assessor-blinded).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of pediatrics Ain Shams University

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 19, 2019
• Study Start: June 9, 2020
• Primary Completion: November 9, 2020
• Study Completion: October 30, 2021
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)