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

December 23, 2022 updated by: Reham Ibrahim, Ain Shams University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Cairo, Egypt, 11757
        • Reham Ibrahim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 months
Child behavior checklist
Time Frame: 3 months
Parent form to asses the associated internalizing and externalizing behaviour
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Conners Continuous Performance Test (CPT)
Time Frame: 3 months
To asses sustained attention and impulsivity
3 months
Wisconsin (Berg) Card Sort Test (WCST)
Time Frame: 3 months
To evaluate executive function
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Reham Ibrahim, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 9, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings