Clinical trial NCT03608735: Prevalence of Functional Gastrointestinal Disorders (FGIDs), Related Signs and Symptoms in Infants/Toddlers in Thailand
Official title: Prevalence of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Gastrointestinal Disorders
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: ObvioHealth
First posted: 2018-08-01
Enrollment: 7908
Sex: ALL
Minimum age (years): 2
Maximum age (years): 19
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: otherwise healthy infants and toddlers aged 2 to 19 months

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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine the ROME IV Criteria score
timeFrame: 1 day
Secondary outcomes:
measure: To measure Quality of Life using modified Pediatric Quality of Life Inventory™
timeFrame: 1 day
Other outcomes:
measure: 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)
timeFrame: 1 day
measure: 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)
timeFrame: 1 day
measure: 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)
timeFrame: 1 day
measure: 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)
timeFrame: 1 day
measure: 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)
timeFrame: 1 day
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
Study officials:
affiliation: Khon Kaen University
name: Busara Charoenwat, MBBS
role: PRINCIPAL_INVESTIGATOR
References: