Functional Gastrointestinal DisordersGI_PlanetNCT03608735
Prevalence of Functional Gastrointestinal Disorders (FGIDs), Related Signs and Symptoms in Infants/Toddlers in Thailand
An observational study of Functional Gastrointestinal Disorders, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Thailand.
Trial summary
Prevalence and impact of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand Read more about this study
- Who is it for?
- Ages 2 to 19 monthsHealthy volunteers can take part
- Conditions the study is for
- Functional Gastrointestinal Disorders
- How many people
- 7,908 participants
- Where
- 1 siteThailand
- Study dates
- 7 Nov 2018to 19 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 19 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: otherwise healthy infants and toddlers aged 2 to 19 months
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand
Prevalence and impact of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand
Read the 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.
- Conditions
- Functional Gastrointestinal Disorders
- Medical subject headings
- Gastrointestinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (1)
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)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start7 Nov 2018
- Primary completion15 Jan 2019
- Study completion19 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 7,908 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ObvioHealth
- Responsible party
- Sponsor
- Investigators
- Busara Charoenwat, MBBS, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608735
- Sponsor's protocol ID
- EBB17GC17070_1 / OBVIO-DAN-004
- Acronym
- GI_Planet
- Status last verified
- Jan 2020
- First submitted
- 17 Jul 2018
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand
- ClinicalTrials.gov ID
- NCT03608735
- Acronym / sponsor ID
- GI_Planet / EBB17GC17070_1 / OBVIO-DAN-004
- Conditions
- Functional Gastrointestinal Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,908 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- ObvioHealth
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 19 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- otherwise healthy infants and toddlers aged 2 to 19 months
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
To measure Quality of Life using modified Pediatric Quality of Life Inventory™
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Busara Charoenwat, MBBS principal investigator
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Gastrointestinal Disorders, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the ROME IV Criteria score (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.