Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms

Not Applicable

• Conditions: Attention Deficit Hyperactivity Disorder

• Registration Number: NCT04333394
• Lead Sponsor: National Nutrition and Food Technology Institute

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.

Study Timeline

• Study First Submitted: 2020-03-24
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-01
• Last Update Submitted: 2020-04-01
• Study First Posted: 2020-04-03
• Last Update Posted: 2020-04-03
• Study Start: 2020-04-20
• Primary Completion: 2020-06
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
symptoms of Attention-deficit hyperactivity disorder (ADHD)	8 weeks	symptoms were assessed using Conners's scale

Trial Locations

Locations (1)

National Nutrition and Food Technology Research Institute; 🇮🇷 Tehrān, Tehran, Iran, Islamic Republic of