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

Functional Gastrointestinal Disorders Clinical Trial

— GI_Planet  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608735
• Other study ID #: EBB17GC17070_1 / OBVIO-DAN-004
• Status: Completed
• Start date: November 7, 2018
• Est. completion date: September 19, 2019

Study information

• Verified date: January 2020
• Source: Danone Asia Pacific Holdings Pte, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7908
• Est. completion date: September 19, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 19 Months

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Signs and Symptoms

Locations

Country	Name	City	State
Thailand	Khon Kaen University	Khon Kaen

Sponsors (2)

Lead Sponsor	Collaborator
Danone Asia Pacific Holdings Pte, Ltd.	ObvioHealth

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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