Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms

Overview

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

Full Title of Study: “Investigating the Effectiveness of Probiotic Supplement in Improving Attention Deficit Hyperactivity Disorder Symptoms in Children”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: June 2020

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 Supplement: Probiotic
  • 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.
• Other: Placebo
  • 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.

Arms, Groups and Cohorts

• Active Comparator: Probiotic
  • The probiotics capsules contain 7 strains of friendly bacteria (Lactobacillus casei PXN 37, Lactobacillus rhamnosus PXN 54, Streptococcus thermophilus PXN 66, Bifidobacterium breve PXN 25, Lactobacillus acidophilus PXN 35, Bifidobacterium longum PXN 30, Lactobacillus bulgaricus PXN 39)
• Placebo Comparator: Placebo
  • Placebo capsules have an identical appearance to probiotic capsules and contain microcrystal cellulose.

Clinical Trial Outcome Measures

Primary Measures

• symptoms of Attention-deficit hyperactivity disorder (ADHD)
  • Time Frame: 8 weeks
  • symptoms were assessed using Conners’s scale
• The severity of the Attention-deficit hyperactivity disorder (ADHD)
  • Time Frame: 8 weeks
  • The severity of the ADHD was assessed using the Clinical Global Impression (CGI) test

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 11 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • National Nutrition and Food Technology Institute
• Provider of Information About this Clinical Study
  • Principal Investigator: Dr Azita Hekmatdoost, Principal Investigator – National Nutrition and Food Technology Institute
• Overall Official(s)
  • Soodeh Razeghi Jahromi, PhD, Study Director, Shahid Beheshti University of Medical Sciences
• Overall Contact(s)
  • Azita Hekmatdoost, MD.PhD, 2122357484, a_hekmat2000@yahoo.com