NCT04333394

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Nutrition and Food Technology Institute · Academic / Other
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-20
• Primary completion: 2020-06-01
• Completion: 2020-08-01
• First posted: 2020-04-03
• Last updated: 2020-04-03

Locations

1 site across 1 country: Iran