Prevalence of Functional Gastrointestinal Disorders (FGIDs), Related Signs and Symptoms in Infants/Toddlers in Thailand (GI_Planet)

Prevalence of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand

Prevalence and impact of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand

Study Overview

• Status: Completed
• Conditions: Functional Gastrointestinal Disorders

Detailed Description

Primary:

To assess the prevalence of specific FGIDs (infant regurgitation, infantile colic and functional constipation) and related signs and symptoms in infants and toddlers in Thailand, according to information provided by the parents.

Secondary:

To assess the impact of FGIDs (Infant regurgitation, Infantile colic and functional constipation) and related signs and symptoms of infants and toddlers on the quality of life (QoL) of parents/caretakers and family, according to information provided by the parents.

Exploratory:

To assess treatments and practices employed in real-life to manage FGIDs according to the Rome IV criteria (infant regurgitation, infantile colic, and functional constipation) and related signs and symptoms in infants and toddlers, according to information provided by the parents.

• Study Type: Observational
• Enrollment (Actual): 7908

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen, Thailand
    • Khon Kaen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

otherwise healthy infants and toddlers aged 2 to 19 months

Description

Inclusion Criteria:

1. Parent of otherwise healthy infants and/or toddlers from one of the age groups: 3±1 months, 6±1 months, 9±1 months, 12±1 months, or 18±1 months
2. Parent answering the online survey questionnaire attends to the child more than 50% of the time
3. Informed consent from one or both parents (according to local laws) and/or legal guardian.
4. Parent should have reliable access to the internet and a reliable device such as a computer, tablet or smartphone to complete the online survey questionnaire

Exclusion Criteria:

1. Parent who is not adequately comfortable in the language in which the online survey questionnaire will be completed
2. Inability of the parent to answer the survey questionnaire online.
3. Infants and Toddlers who underwent surgery under general anesthesia

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the ROME IV Criteria score	FGIDs according to the ROME IV criteria (infant regurgitation, infantile colic, and functional constipation), related signs and symptoms in infants and toddlers based on parent's response in the survey questionnaires. Scale measures 1-7	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure Quality of Life using modified Pediatric Quality of Life Inventory™	Pediatric Quality of Life Inventory of the parents/caretakers and the family (using modified PedsQL™ Family Impact Module, Scale 0 -144)	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine use of medication for the management of FGID via Adapted Parent Report Form for Infants and Toddlers Questionnaire on Paediatric Gastrointestinal Symptoms, Rome IV (R4PDQ-toddler)	Use of medications for FGIDs and related signs and symptoms Use of treatments (other than medications or nutritional supplements) for FGIDs and related signs and symptoms Use of nutritional supplements for FGIDs and related signs and symptoms Use of other remedies for FGIDs and related signs and symptoms Visit to doctor, healthcare professional, clinic, and/or hospital for FGIDs and related signs and symptoms	1 day
To determine use of treatment for the management of FGID via Adapted Parent Report Form for Infants and Toddlers Questionnaire on Paediatric Gastrointestinal Symptoms, Rome IV (R4PDQ-toddler)	Use of treatment (other than medication) for FGIDs and related signs and symptoms Use of treatments (other than medications or nutritional supplements) for FGIDs and related signs and symptoms Use of nutritional supplements for FGIDs and related signs and symptoms Use of other remedies for FGIDs and related signs and symptoms Visit to doctor, healthcare professional, clinic, and/or hospital for FGIDs and related signs and symptoms	1 day
To determine use of nutritional supplements for the management of FGID via Adapted Parent Report Form for Infants and Toddlers Questionnaire on Paediatric Gastrointestinal Symptoms, Rome IV (R4PDQ-toddler)	Use of supplements for FGIDs and related signs and symptoms Use of treatments (other than medications or nutritional supplements) for FGIDs and related signs and symptoms Use of nutritional supplements for FGIDs and related signs and symptoms Use of other remedies for FGIDs and related signs and symptoms Visit to doctor, healthcare professional, clinic, and/or hospital for FGIDs and related signs and symptoms	1 day
To determine use of other remedies for the management of FGID via Adapted Parent Report Form for Infants and Toddlers Questionnaire on Paediatric Gastrointestinal Symptoms, Rome IV (R4PDQ-toddler)	Use of other remedies (other than medication, supplements) for FGIDs and related signs and symptoms Use of treatments (other than medications or nutritional supplements) for FGIDs and related signs and symptoms Use of nutritional supplements for FGIDs and related signs and symptoms Use of other remedies for FGIDs and related signs and symptoms Visit to doctor, healthcare professional, clinic, and/or hospital for FGIDs and related signs and symptoms	1 day
Visit to doctor, healthcare professional, clinic, and/or hospital for FGIDs and related signs and symptoms via Adapted Parent Report Form for Infants and Toddlers Questionnaire on Paediatric Gastrointestinal Symptoms, Rome IV (R4PDQ-toddler)	Visit to doctor, healthcare professional, clinic, and/or hospital for FGIDs and related signs and symptoms	1 day

Collaborators and Investigators

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
• Collaborators: ObvioHealth
• Investigators: Principal Investigator: Busara Charoenwat, MBBS, Khon Kaen University

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2018
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): September 19, 2019

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: EBB17GC17070_1 / OBVIO-DAN-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No