Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-28 @ 12:06 AM
Study NCT ID:
NCT04333394
Status:
UNKNOWN
Last Update Posted:
2020-04-03
First Post:
2020-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms
Sponsor:
National Nutrition and Food Technology Institute
Organization:
Study Overview
Official Title:
Investigating the Effectiveness of Probiotic Supplement in Improving Attention Deficit Hyperactivity Disorder Symptoms in Children
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: