Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms

NCT04333394 | Unknown DMC

• 1 other identifier: 96/114
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD, Probiotics, Children

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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)

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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.

Probiotic

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.

Placebo

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead

Study Sites (1)

National Nutrition and Food Technology Research Institute

Tehrān, Tehran Province, 19395-4741, Iran

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Soodeh Razeghi Jahromi, PhD

  Shahid Beheshti University of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Azita Hekmatdoost, MD.PhD

CONTACT

2122357484; a_hekmat2000@yahoo.com

Azita Hekmatdoost

CONTACT

a_hekmat2000@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: April 3, 2020
• Study Start: April 20, 2020
• Primary Completion: June 1, 2020
• Study Completion: August 1, 2020
• Last Updated: April 3, 2020

Record last verified: 2020-04

Locations

IR (1)