Prevalence of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Gastrointestinal Disorders
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Enrollment
- 7908
- Locations
- 1
- Primary Endpoint
- To determine the ROME IV Criteria score
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Parent answering the online survey questionnaire attends to the child more than 50% of the time
- •Informed consent from one or both parents (according to local laws) and/or legal guardian.
- •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
- •Parent who is not adequately comfortable in the language in which the online survey questionnaire will be completed
- •Inability of the parent to answer the survey questionnaire online.
- •Infants and Toddlers who underwent surgery under general anesthesia
Outcomes
Primary Outcomes
To determine the ROME IV Criteria score
Time Frame: 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 Outcomes
- To measure Quality of Life using modified Pediatric Quality of Life Inventory™(1 day)