The Effectiveness of Treatment with Probiotic Supplements Added to the Usual Treatment (Medical Treatment for Children with Parenting Training Sessions for Parents) in Children Suffering from Attention Deficit-Hyperactivity Disorder Referred to Specialized Treatment Centers for Child and Adolescent Psychiatry
The effectiveness of treatment with probiotic supplements added to the usual treatment in children with attention deficit-hyperactivity disorder
Design
A clinical trial with a control group, with a parallel group, double-blind, randomized on 80 patients
Settings and conduct
Study is conducted in psychiatric clinics and on children aged 6 to 12 With attention deficit-hyperactivity disorder. Children will be given medicine and placebo in two groups. Questionnaires will be filled by the before, during and after the study. The presenter, parents and children will not know about the child's group.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1- 6 to 12 years old children with ADHD .
2- Not change in their treatment regimen in the last two months.
Non-entry criteria:
1- Who take antidepressant, anti psychotic and mood stabilizer drugs.
2- Who have anxiety according to Hamilton questionnaire and have depression according to children depression inventory.
Intervention groups
Before and after the parenting training session, a test (questionnaire) will be taken from both groups. Then, we ask the intervention group to take 200 mg probiotic capsules for 1 and a half months in addition to their usual treatment, and then they will be tested again. In the control group, 200 mg placebo capsules were prescribed in addition to their usual treatment, and they were tested again after 1 and a half months.
Main outcome variables
َAttention deficit-hyperactivity disorder status.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211004052670N6
Registration date:2024-01-20, 1402/10/30
Registration timing:registered_while_recruiting
Last update:2024-01-20, 1402/10/30
Update count:0
Registration date
2024-01-20, 1402/10/30
Registrant information
Name
afsaneh karbasi amel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3641 1255
Email address
afsaneh_karbasi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Treatment with Probiotic Supplements Added to the Usual Treatment (Medical Treatment for Children with Parenting Training Sessions for Parents) in Children Suffering from Attention Deficit-Hyperactivity Disorder Referred to Specialized Treatment Centers for Child and Adolescent Psychiatry
Public title
The Effectiveness of Probiotic Supplements in Attention Deficit-Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with Attention Deficit-Hyperactive Disorder with 6 to 12 years old.
No change in treatment regimen during the last two months.
Consent to participate in the study.
Exclusion criteria:
Taking anti-depressant drugs, anti-psychotic drugs and mood stabilizers.
Children with anxiety (based on Hamilton Rating Scale for Depression) and with depression (based on Children Depression Inventory).
Children with Inflammatory Bowel Disease, Celiac disease and Irritable bowel syndrome.
Children with Diabetes.
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 80 eligible patients are randomly selected. For this, the letter A written on 40 sheets, the letter B written on 40 sheets, and each of them is placed in an envelope. Each patients is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to observe blindness, the drugs (medicine and placebo) are prepared in the same shape before the intervention and are coded and given to the physician. They prescribe them without knowing the type of each drug. Therefore, the patient,the person recording the clinical and baseline information of the patients as well as the statistical analyst will not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Ibn Sina Street, Amin Hospital, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8148653141
Approval date
2023-07-14, 1402/04/23
Ethics committee reference number
IR.MUI.MED.REC.1402.150
Health conditions studied
1
Description of health condition studied
Attention deficit-hyperactivity disorder
ICD-10 code
F90.2
ICD-10 code description
Attention-deficit hyperactivity disorder, combined type
Primary outcomes
1
Description
Attention deficit-hyperactivity scale in attention deficit-hyperactivity rating scale
Timepoint
The questionnaire is filled in at the baseline visit and after 15 days of participating in parent training sessions (before the start of the intervention) and then 45 days later and after the end of taking the drug.
Method of measurement
Attention deficit-hyperactivity rating scale.
2
Description
Attention deficit-hyperactivity scale in Connors questionnaire.
Timepoint
The questionnaire is filled in at the baseline visit and after 15 days of participating in parent training sessions (before the start of the intervention) and then 45 days later and after the end of taking the drug.
Method of measurement
Connors questionnaire
3
Description
Quality of life score in Pediatric's Quality of Life Questionnaire.
Timepoint
The questionnaire is filled in at the baseline visit and after 15 days of participating in parent training sessions (before the start of the intervention) and then 45 days later and after the end of taking the drug.
Method of measurement
Pediatric's Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control groupThe control group was instructed to administer a capsule (contains placebo) once daily for a duration of 1.5 months concurrently with their routine medication. Drug utilization was communicated through a telephonic announcement, adhering to the guidelines provided by the pharmaceutical manufacturer (Amin Lab) and informed by extant research. Preceding the intervention, parent management training sessions were conducted for the participating parents.
Category
Placebo
2
Description
Intervention group: The intervention group was instructed to administer a capsule (probiotics capsule 200 mg) once daily for a duration of 1.5 months concurrently with their routine medication. Drug utilization was communicated through a telephonic announcement, adhering to the guidelines provided by the pharmaceutical manufacturer (Amin Lab) and informed by extant research. Preceding the intervention, parent management training sessions were conducted for the participating parents.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Karbasi Amel Afsaneh
Street address
Ibn Sina Street, Amin Hospital,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3445 5051
Email
Afsanehkarbasi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
غلامرضا عسگری
Street address
Hazarjarib St. Isfahan University of Medical Sciences,Isfahan,Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?