The Prevalence and Predictors of Gastrointestinal Symptoms in Children With Attention Deficit / Hyperactivity Disorder

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

The Prevalence and Predictors of Gastrointestinal Symptoms in Children With Attention Deficit / Hyperactivity Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03879343
• Other study ID #: 2018.285
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: July 2019

Study information

• Verified date: March 2019
• Source: Hospital Authority, Hong Kong
• Contact: Jonathan Siu Fung Ng
• Phone: 852 26892000
• Email: nsf600[@]ha.org.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is to examine the gut problems in children with attention deficit hyperactivity disorders (ADHD) and is conducted by the Department of Psychiatry of Alice Ho Miu Ling Nethersole Hospital. Children with ADHD who attend our department will be recruited with their parents/guardians' consent. Only the primary caregiver will be invited for an interview to assess the recruited children's gut problems, autistic features, emotional problems, diet pattern and medical history. The data will be compared with normal children who are recruited as control in local primary schools. The aim of this study is to know whether children with ADHD have higher chance of gut problems, and to assess other factors associated with the linkage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 137
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

Inclusion Criteria:

• The study group will be recruited if the following criteria are met:

1. Aged 6 to 11 years old

2. Children with a diagnosis of ADHD made by psychiatrists according to Diagnostic and Statistical Manual for Mental Disorder, fifth edition criteria

3. Currently study in mainstream schools in Hong Kong

The control group will be recruited if the following criteria are met:

1. Age 6 to 11 years old

2. Currently study in mainstream schools in Hong Kong

3. Typically developing in good mental and physical health

Exclusion Criteria:

• For both groups, the participant will be excluded if the following criterion is met:

1. Children who are suffering from mental retardation

2. Children who are suffering from organic illnesses that affect gastrointestinal function

3. Children who are suffering from severe mental illnesses

4. Children who have ever received, or are currently on, medication for ADHD

5. Children who are currently taking medication for illnesses other than ADHD

6. Primary caregiver does not understand Chinese

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Digestive System Diseases
• Disease
• Gastrointestinal Diseases
• Hyperkinesis

Intervention

Other:
• Known diagnosis of attention deficit / hyperactivity disorder
Clinical group includes subjects with clinical diagnosis of attention deficit / hyperactivity disorder

Locations

Country	Name	City	State
Hong Kong	Alice Ho Miu Ling Nethersole Hospital	Tai Po	New Territories

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong	Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of children with ADHD had gastrointestinal (GI) symptoms	Functional gastrointestinal symptoms as measured by Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PGD)	One month prior to interview
Secondary	The number of children with ADHD had GI symptoms after controlling for the potential confounding factors including co-morbid autism spectrum disorder (ASD) symptoms, emotional symptoms and diet pattern		One month prior to interview