to evaluate the effect of probiotic in the treatment of ADHD children
Design
Triple blind parallel randomized controlled trial
intervention group: ADHD treatment + probiotic
control group: ADHD treatment + placebo
n= 30 patients in each group
Settings and conduct
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)
Participants/Inclusion and exclusion criteria
4-16 year old children with ADHD, without any treatment in the last 2 months
ADHD scale using ADHD rating scale or Conner’s parent rating scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181022041407N1
Registration date:2018-11-02, 1397/08/11
Registration timing:prospective
Last update:2018-11-02, 1397/08/11
Update count:1
Registration date
2018-11-02, 1397/08/11
Registrant information
Name
Maryam Emadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9262
Email address
emadzadehm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of probiotic on the treatment of ADHD children
Public title
evaluation the effect of probiotic on treatment of ADHD children
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 4 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization
Randomization Method: excel software or other randomization websites
Allocation Concealment: opaque envelope
Blinding (investigator's opinion)
Triple blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Research Ethics Committee, School of Medicine- Mashhad University of Medical Sciences
Street address
Azadi Square, University Campus, Faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2018-09-05, 1397/06/14
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.030
Health conditions studied
1
Description of health condition studied
ADHD
ICD-10 code
F90.9
ICD-10 code description
Attention-deficit hyperactivity disorder, unspecified type
Primary outcomes
1
Description
evaluation of ADHD scale with specific questionnaires like ADHD rating scale or Conner’s parent rating scale
Timepoint
4 and 8 weeks after the first visit
Method of measurement
ADHD rating scale or Conner’s parent rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: ADHD treatment + probiotic
Category
Treatment - Drugs
2
Description
Control group: ADHD treatment + placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn-e-Sina Hospital, Psychiatric Clinic
Full name of responsible person
Maryam Emadzadeh
Street address
Ibn-e-Sina Hospital, Hor-e-Ameli Street
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
maryamemadzadeh@yahoo.com
Web page address
http://sina.mums.ac.ir/index.php
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreyshi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
presidentoffice@mums.ac.ir
Web page address
http://www.mums.ac.ir/
Grant name
Mashhad University of Medical Sciences
Grant code / Reference number
961476
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Research Institute of Food Science and Technology
Full name of responsible person
Mahdi Ziaratnia
Street address
km. 12- Mashhad/ Quchan Highway
City
Mashhad
Province
Razavi Khorasan
Postal code
9185176933
Phone
+98 51 3542 5421
Fax
+98 51 3542 5406
Email
info@rifst.ac.ir
Web page address
https://www.rifst.ac.ir/
Grant name
Research grant of Research Institute of Food Science and Technology
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute of Food Science and Technology
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Emadzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Department of Community Medicine, Faculty of Medicine, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9262
Email
maryamemadzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Emadzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Department of Community Medicine, Faculty of Medicine, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9262
Email
maryamemadzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Emadzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Department of Community Medicine, Faculty of Medicine, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9262
Email
maryamemadzadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available