Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms

Not Applicable

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Dietary Supplement: Probiotic; Other: Placebo

• 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

Arm && Interventions

Group	Intervention	Description
Probiotic	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	Placebo	Placebo capsules have an identical appearance to probiotic capsules and contain microcrystal cellulose.

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