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

NCT ID: NCT04167995

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-09

Study Completion Date

2021-10-30

Brief Summary

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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

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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.

Conditions

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Inattentive Hyperactivity Impulsivity

Keywords

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Hyperactivity Inattention Probiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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).

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Probiotic Formula lacteal forte

Intervention Type 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 .

ADHD not receiving probiotics

ADHD patient (40) on standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 .

Intervention Type DRUG

Other Intervention Names

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Lacteal forte

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Reham Ibrahim

Associate professor of pediatrics Ain Shams University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reham Ibrahim

Role: STUDY_DIRECTOR

Ain Shams University

Locations

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Reham Ibrahim

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 37946220 (View on PubMed)

Other Identifiers

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FWA 000017

Identifier Type: -

Identifier Source: org_study_id