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Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Probiotic

Placebo

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Probiotics, Children

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

National Nutrition and Food Technology Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

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 capsules have an identical appearance to probiotic capsules and contain microcrystal cellulose.

Outcomes

Primary Outcome Measures

symptoms of Attention-deficit hyperactivity disorder (ADHD)

symptoms were assessed using Conners's scale

The severity of the Attention-deficit hyperactivity disorder (ADHD)

The severity of the ADHD was assessed using the Clinical Global Impression (CGI) test

Secondary Outcome Measures

Full Information

NCT ID

NCT04333394

First Posted

March 24, 2020

Last Updated

April 1, 2020

Sponsor

National Nutrition and Food Technology Institute

1. Study Identification

Unique Protocol Identification Number

NCT04333394

Brief Title

Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 20, 2020 (Anticipated)

Primary Completion Date

June 2020 (Anticipated)

Study Completion Date

August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Nutrition and Food Technology Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

Keywords

ADHD, Probiotics, Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Probiotic

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo capsules have an identical appearance to probiotic capsules and contain microcrystal cellulose.

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotic

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

symptoms of Attention-deficit hyperactivity disorder (ADHD)

Description

symptoms were assessed using Conners's scale

Time Frame

8 weeks

Title

The severity of the Attention-deficit hyperactivity disorder (ADHD)

Description

The severity of the ADHD was assessed using the Clinical Global Impression (CGI) test

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Azita Hekmatdoost, MD.PhD

Phone

2122357484

a_hekmat2000@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Azita Hekmatdoost

a_hekmat2000@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Soodeh Razeghi Jahromi, PhD

Organizational Affiliation

Shahid Beheshti University of Medical Sciences

Official's Role

Study Director

Facility Information:

Facility Name

National Nutrition and Food Technology Research Institute

City

Tehrān

State/Province

Tehran

ZIP/Postal Code

19395-4741

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

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Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms

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