Clinical trial of the effect of probiotic supplementation compared with the placebo on clinical status and metabolic profiles in children with attention deficit hyperactivity disorder undergoing Ritalin treatment
Objective: The aim of this study is to determine the effects of probiotic supplementation on clinical status and metabolic profiles in children with attention deficit hyperactivity disorder (ADHD). Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: children aged 8-12 years diagnosed with ADHD based on DSM-IV criteria will be included in this study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among children with ADHD referred to Kargarnejad clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned to two groups to receive probiotic supplement (n=30) or placebo (n=30). probiotic and placebo sachets are similar in shape. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and end of the intervention: 8 weeks. Outcomes: ADHD rating scale (primary outcome) and inflammatory factors, biomarkers of oxidative stress, depression and anxiety (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017090133941N16
Registration date:2017-11-01, 1396/08/10
Registration timing:retrospective
Last update:
Update count:2
Registration date
2017-11-01, 1396/08/10
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-06-05, 1396/03/15
Expected recruitment end date
2017-09-06, 1396/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of probiotic supplementation compared with the placebo on clinical status and metabolic profiles in children with attention deficit hyperactivity disorder undergoing Ritalin treatment
Public title
Effect of probiotic supplementation in treatment of children with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children aged between 8 and 12 years; diagnosed with attention deficit hyperactivity disorder based on DSM-IV criteria. Exclusion Criteria: Unwillingness to cooperate.
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Approval date
2016-09-27, 1395/07/06
Ethics committee reference number
IR.KAUMS.REC.1395.59
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
ADHD rating scale
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Hs-CRP
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Elisa kit
2
Description
Nitric oxide
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Glutathione
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Hamilton Anxiety Rating scale
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Questionnaire
7
Description
depression
Timepoint
At the beginning of the study and after 8 weeks of intervention