Protocol summary
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Study aim
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to evaluate the effect of probiotic in the treatment of ADHD children
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Design
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Triple blind parallel randomized controlled trial
intervention group: ADHD treatment + probiotic
control group: ADHD treatment + placebo
n= 30 patients in each group
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Settings and conduct
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4-16 year old ADHD patients who are referred to Ibn-e-Sina psychiatric clinic enter to this study(after their parents sign the informed consent form). Patients randomly divide to 2 groups: intervention(ADHD treatment + probiotic) and control(ADHD treatment + placebo). All patients, assessors and analyzer are blind(more description about blinding is presented in the specific part for blinding)
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Participants/Inclusion and exclusion criteria
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4-16 year old children with ADHD, without any treatment in the last 2 months
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Intervention groups
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intervention group: ADHD treatment + probiotic
control group: ADHD treatment + placebo
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Main outcome variables
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ADHD scale using Conner’s parent rating scale.
Integrated Visual and Auditory Continues Performance Test (IVA/CPT)
General information
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Reason for update
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As the industrial phase of the study took about two years, at the time of trial registration in IRCT, we wrote that we will use either Conner`s parent rating scale or ADHD rating scale as the primary outcome in clinical phase. After completing the industrial phase, it was decided to use the Conner`s parent rating scale (CPRS). So, we updated this part
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181022041407N1
Registration date:
2018-11-02, 1397/08/11
Registration timing:
prospective
Last update:
2023-05-20, 1402/02/30
Update count:
1
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Registration date
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2018-11-02, 1397/08/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-03-20, 1399/01/01
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Expected recruitment end date
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2020-10-22, 1399/08/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the effectiveness of probiotic on the treatment of ADHD children
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Public title
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evaluation the effect of probiotic on treatment of ADHD children
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
4-16 year old children
New case of ADHD diagnosed by psychiatrist
Exclusion criteria:
History of treatment because of ADHD in the last 2 months
Other psychological problems
Mental Retardation
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Age
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From 4 years old to 16 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple Randomization
Randomization Method: excel software or other randomization websites
Allocation Concealment: opaque envelope
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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After the description about the method and aim of the study and informed consents of parents, randomization will be done. The type of treatment is written with odds and even number in separate papers and placed in an opaque envelope. After the psychiatrist visits the patients, if the patients have the inclusion criteria, the method of the study will describe to the parents. If they agree to participate in this study, the informed consent form must be completed. Then the psychiatrist will take an envelope and write the patients characteristic with the special number(odds or even) in the list. So, patients and psychiatrist only know the number (not the intervention or control group). After the special time, the assessor evaluates the children with the specific questionnaire. He does not know which group the patient is (blind). Then the complete data will b presented to the analyzer for data analysis. In the datasheet the group will type as odd/even numbers(not the group names), so the analyzer is blind too.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-09-05, 1397/06/14
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1397.030
Health conditions studied
1
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Description of health condition studied
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ADHD
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ICD-10 code
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F90.9
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ICD-10 code description
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Attention-deficit hyperactivity disorder, unspecified type
Primary outcomes
1
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Description
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evaluation of ADHD scale with Conner’s parent rating scale
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Timepoint
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Baseline, 4 and 8 weeks after the first visit
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Method of measurement
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Conner’s parent rating scale
Secondary outcomes
1
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Description
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Integrated Visual and Auditory Continues Performance Test (IVA/CPT)
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Timepoint
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Baseline and after 8 weeks
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Method of measurement
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A computerized standardized test consists of both auditory and visual parts
Intervention groups
1
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Description
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Intervention group: ADHD treatment + probiotic
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Category
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Treatment - Drugs
2
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Description
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Control group: ADHD treatment + placebo
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Category
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Placebo
1
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Sponsor
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Grant name
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Mashhad University of Medical Sciences
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Grant code / Reference number
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961476
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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80
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Research grant of Research Institute of Food Science and Technology
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Research Institute of Food Science and Technology
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Proportion provided by this source
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20
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available