Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms

Investigating the Effectiveness of Probiotic Supplement in Improving Attention Deficit Hyperactivity Disorder Symptoms in Children

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

Study Overview

• Status: Unknown
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Dietary supplement: Probiotic; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Azita Hekmatdoost, MD.PhD; Phone Number: 2122357484; Email: a_hekmat2000@yahoo.com
• Study Contact Backup: Name: Azita Hekmatdoost; Email: a_hekmat2000@yahoo.com

Study Locations

• Iran, Islamic Republic of
  • Tehran
    • Tehrān, Tehran, Iran, Islamic Republic of, 19395-4741
      • National Nutrition and Food Technology Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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.
Placebo Comparator: Placebo; Placebo capsules have an identical appearance to probiotic capsules and contain microcrystal cellulose.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Nutrition and Food Technology Institute
• Investigators: Study Director: Soodeh Razeghi Jahromi, PhD, Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): April 20, 2020
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: ADHD, Probiotics, Children
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 96/114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No