Clinical trial NCT04333394: Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms
Official title: Investigating the Effectiveness of Probiotic Supplement in Improving Attention Deficit Hyperactivity Disorder Symptoms in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD, Probiotics, Children
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: symptoms of Attention-deficit hyperactivity disorder (ADHD)
timeFrame: 8 weeks
measure: The severity of the Attention-deficit hyperactivity disorder (ADHD)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehrān
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
state: Tehran
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Soodeh Razeghi Jahromi, PhD
role: STUDY_DIRECTOR
References: