Prevalence of Functional Gastrointestinal Disorders (FGIDs), Related Signs and Symptoms in Infants/Toddlers in Thailand
GI_Planet
1 other identifier
observational
7,908
1 country
1
Brief Summary
Prevalence and impact of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2018
CompletedFirst Posted
Study publicly available on registry
August 1, 2018
CompletedStudy Start
First participant enrolled
November 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2019
CompletedJanuary 6, 2020
January 1, 2020
2 months
July 17, 2018
January 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To measure Quality of Life using modified Pediatric Quality of Life Inventory™
1 day
Other Outcomes (5)
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)
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)
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)
1 day
- +2 more other outcomes
Eligibility Criteria
otherwise healthy infants and toddlers aged 2 to 19 months
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Danone Asia Pacific Holdings Pte, Ltd.lead
- ObvioHealthcollaborator
Study Sites (1)
Khon Kaen University
Khon Kaen, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Busara Charoenwat, MBBS
Khon Kaen University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2018
First Posted
August 1, 2018
Study Start
November 7, 2018
Primary Completion
January 15, 2019
Study Completion
September 19, 2019
Last Updated
January 6, 2020
Record last verified: 2020-01