InattentiveEarly Phase 1ADHDNCT04167995
Assessment of Probiotics Lactobacillus in the Management of Attention Deficit Hyperactive Disorder
A Early Phase 1 study testing Probiotic Formula lacteal forte in people with Inattentive and Hyperactivity, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Inattentive, Hyperactivity, Impulsivity
- What is being tested?
- Probiotic Formula lacteal forte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jun 2020to 30 Oct 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age from 6 to 16 years old.
- Children fulfilled DSM(V) Criteria for ADHD syndrome.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Inattentive, Hyperactivity, Impulsivity
- Being tested
- Probiotic Formula lacteal forte
- Keywords
- Hyperactivity, Inattention, Probiotics
- Medical subject headings
- Spasm, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Formula lacteal forteDrug
Also called 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 .
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Probiotic Formula lacteal forte |
| ADHD not receiving probiotics | No intervention | ADHD patient (40) on standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Child behavior checklist
Parent form to asses the associated internalizing and externalizing behaviour
Measured: 3 months
Secondary outcomes (2)
Conners Continuous Performance Test (CPT)
To asses sustained attention and impulsivity
Measured: 3 months
Wisconsin (Berg) Card Sort Test (WCST)
To evaluate executive function
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start9 Jun 2020
- Primary completion9 Nov 2020
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InattentiveStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Ibrahim, Ain Shams University
- Investigators
- Reham Ibrahim, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167995
- Sponsor's protocol ID
- FWA 000017
- Acronym
- ADHD
- Status last verified
- Dec 2022
- First submitted
- 12 Nov 2019
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37946220
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04167995
- Acronym / sponsor ID
- ADHD / FWA 000017
- Conditions
- Inattentive, Hyperactivity, Impulsivity
- Keywords
- Hyperactivity, Inattention, Probiotics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with attention deficit hyperactive disorser | Active comparator | Drug: Probiotic Formula lacteal fortepatients (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 |
| ADHD not receiving probiotics | No intervention | –ADHD patient (40) on standard treatment |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age from 6 to 16 years old.
- Children fulfilled DSM(V) Criteria for ADHD syndrome.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Formula lacteal forteAlso: Lacteal forteActive 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 . | Drug | Patient with attention deficit hyperactive disorser |
Primary outcome
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
Child behavior checklist
Time frame: 3 months
Parent form to asses the associated internalizing and externalizing behaviour
2 secondary outcomes
Conners Continuous Performance Test (CPT)
Time frame: 3 months
Wisconsin (Berg) Card Sort Test (WCST)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Derived from this study: PubMed 37946220Elhossiny 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reham Ibrahim study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Probiotic Formula lacteal forte in people with Inattentive and Hyperactivity, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conner's Parent Rating Scales-Revised (CRS-R):for follow up (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04167995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.