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

• Sponsor: Hospital Authority, Hong Kong (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03879343
• Collaborator: Chinese University of Hong Kong (Other)
• Enrollment: 137
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 11.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity; Gastrointestinal Diseases	Other: Known diagnosis of attention deficit / hyperactivity disorder

Study Design

• Study Type: Observational
• Anticipated Enrollment: 137 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Prevalence and Predictors of Gastrointestinal Symptoms in Children With Attention Deficit / Hyperactivity Disorder
• Actual Study Start Date: Jul 1, 2018
• Anticipated Primary Completion Date: Jul 1, 2019
• Anticipated Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Clinical group Children aged six to eleven with clinical diagnosis of attention deficit / hyperactivity disorder were recruited for interview and completion of questionnaires	Other: Known diagnosis of attention deficit / hyperactivity disorder; Clinical group includes subjects with clinical diagnosis of attention deficit / hyperactivity disorder
Control group Normally developing children aged six to eleven studying in local mainstream primary schools were recruited for completion of questionnaires

Outcome Measures

Primary Outcome Measures

1. The number of children with ADHD had gastrointestinal (GI) symptoms [One month prior to interview]

   Functional gastrointestinal symptoms as measured by Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PGD)

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alice Ho Miu Ling Nethersole Hospital	Tai Po	New Territories	Hong Kong

Sponsors and Collaborators

• Hospital Authority, Hong Kong
• Chinese University of Hong Kong

Investigators

• Principal Investigator: Jonathan Siu Fung Ng, Hospital Authority, Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NG SIU FUNG JONATHAN, Principal investigator, Hospital Authority, Hong Kong
• ClinicalTrials.gov Identifier: NCT03879343
• Other Study ID Numbers: 2018.285
• First Posted: Mar 18, 2019
• Last Update Posted: Mar 19, 2019
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Hyperkinesis; Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Mar 19, 2019