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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator | 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 Comparator | Placebo capsules have an identical appearance to probiotic capsules and contain microcrystal cellulose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Azita Hekmatdoost, MD.PhD | Contact | 2122357484 | a_hekmat2000@yahoo.com | |
| Azita Hekmatdoost | Contact | a_hekmat2000@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Soodeh Razeghi Jahromi, PhD | Shahid Beheshti University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Nutrition and Food Technology Research Institute | Tehrān | Tehran Province | 19395-4741 | Iran |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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The present study will be conducted as a phase 3, randomized double-blind placebo-controlled trial on 40 attention deficit hyperactivity disorder patients allocated in 2 parallel groups each consisted of 20 patients who will receive Probiotic or placebo. From the beginning of the study, A and B codes are available to researchers to recruit the patients using ten 4-Block Randomization.
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Both patients and researchers won't be aware of the treatments patients receiving in this study (unaware of the quiddity of A and B capsules), so the study has a double-blind design. Only one of the staff of the company that supplied the Probiotic supplement is aware of the type of assigned intervention for each patient. After collecting the data, he will unseal the codes for researchers, the statistical analyst, participants and those who prepare the manuscript.
| Placebo | Other | 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. |
|
| D019602 |
| Food and Beverages |