Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04333394
• Other study ID #: 96/114
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2020
• Est. completion date: August 2020

Study information

• Verified date: April 2020
• Source: National Nutrition and Food Technology Institute
• Contact: Azita Hekmatdoost, MD.PhD
• Phone: 2122357484
• Email: a_hekmat2000[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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)

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	National Nutrition and Food Technology Research Institute	Tehran	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptoms of Attention-deficit hyperactivity disorder (ADHD)	symptoms were assessed using Conners's scale	8 weeks
Primary	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