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

Completed

• Conditions: Functional Gastrointestinal Disorders

• Registration Number: NCT03608735
• Lead Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-01
• Study Start: 2018-11-07
• Primary Completion: 2019-01-15
• Study Completion: 2019-09-19
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-03
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7908

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the ROME IV Criteria score	1 day	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Khon Kaen University; 🇹🇭 Khon Kaen, Thailand