Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ADHD, Probiotics, Children
Brief summary
To study the effects of probiotic supplement in children with Attention-deficit hyperactivity disorder (ADHD),40 patients will be randomly allocated to two groups of intervention and placebo. The intervention and the placebo group will be prescribed with 1 capsule of probiotics and placebo for 8 weeks, respectively. Treatment efficacy will be assessed via administrating the Conners's rating
Detailed description
Both probiotics and placebo groups will receive medication with Ritalin in a dose-dependent manner, starting at the onset of the study and simultaneous with probiotic supplementation. Children weighed 30 Kg or less receive 0.3 mg/kg of Ritalin in 3 separate intervals and after four weeks the dosage will increase to 0.5mg/kg. Those who weighed more than 30 kg receive 0.5 mg/kg with the same pattern that reaches the highest point of 0.7 mg/kg by week four. Each dosage will be administrated trice a day with breakfast, lunch, and dinner. In the middle of the study patients who consumes less than 80% of their supplements will be omitted from the study.
Interventions
DIETARY_SUPPLEMENTProbiotic
The probiotic capsules will be administrated once a day. medication with Ritalin starts at the onset of the study in a dose-dependent manner and simultaneous with probiotic supplementation.
OTHERPlacebo
The placebo capsules will be administered once a day. medication with Ritalin starts at the onset of the study in a dose-dependent manner and simultaneous with placebo supplementation.
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Both patients and researchers won't be aware of the treatments patients receiving in this study (unaware of the quiddity of A and B capsules), so the study has a double-blind design. Only one of the staff of the company that supplied the Probiotic supplement is aware of the type of assigned intervention for each patient. After collecting the data, he will unseal the codes for researchers, the statistical analyst, participants and those who prepare the manuscript.
Intervention model description
The present study will be conducted as a phase 3, randomized double-blind placebo-controlled trial on 40 attention deficit hyperactivity disorder patients allocated in 2 parallel groups each consisted of 20 patients who will receive Probiotic or placebo. From the beginning of the study, A and B codes are available to researchers to recruit the patients using ten 4-Block Randomization.
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of Attention Deficit Hyperactivity Disorder * Having an Intelligence quotient more than 85 based on Wechsler test for children * Willing to participate in the study
Exclusion criteria
* History of any other mental and psychological disorder such as depression, chronic motor tic disorder, communication disorder, learning disability * Taking any stimulant, sedative, anti-anxiety and anti-psychotic medications * History of any chronic disorders, requiring long term medication (such as cancers, Cirrhosis, autoimmune disorders, metabolic disorders ) or, chronic neurological disorders (such as epilepsy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| symptoms of Attention-deficit hyperactivity disorder (ADHD) | 8 weeks | symptoms were assessed using Conners's scale |
| The severity of the Attention-deficit hyperactivity disorder (ADHD) | 8 weeks | The severity of the ADHD was assessed using the Clinical Global Impression (CGI) test |
Countries
Iran
Contacts
Primary ContactAzita Hekmatdoost, MD.PhD
Backup ContactAzita Hekmatdoost
Outcome results
None listed