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Asian Morbidity Survey (Vietnam)


- candidate number29578
- NTR NumberNTR7495
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-sep-2018
- Secondary IDsLAG100 (VN) - 2018 
- Public TitleAsian Morbidity Survey (Vietnam)
- Scientific TitleAsian Morbidity Survey (Vietnam)
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedFunctional abdominal pain, Constipation, Diarrhea, Gastrointestinal disease
- Inclusion criteria1. Infants and toddlers aged between 0 to 48 months old who are healthy children with normal physical development (according to growth chart) and physical examination (by pediatricians), will be eligible for enrolment
2. No organic gastrointestinal disorders
- Exclusion criteria1. Infants and toddlers who are identified as having organic gastrointestinal disorders (by pediatricians)
2. Infants and toddlers who have physical and/or mental retardation
3. Infants and toddlers who have had gastrointestinal surgeries
4. If, in the investigator's opinion, continuation in the survey would be detrimental to the subject’s well-being
5. Infants and toddlers who are lost to follow-up
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-nov-2018
- planned closingdate30-apr-2019
- Target number of participants1500
- InterventionsNA; this is an observational study
- Primary outcomePrevalence of infant colic
Prevalence of infant regurgitation
Prevalence of dyschezia
Prevalence of functional diarrhea
Prevalence of functional constipation
- Secondary outcome1. To identify risk factors associated with the development of FGD’s, such as demographic data, exposure to traumatic events, social and economic factors. The questionnaire will obtain family information (part 3 of the Questionnaire Assessment of functional gastrointestinal disorder) which could indicate the above risk factors.
2. To explore the relationship between various food groups and gastrointestinal symptoms in infants and toddlers between the age of 6.1 months – 48 months old.
3. To evaluate the accuracy of the criteria for diagnosis, using short-term clinical follow-up as the gold standard.
- TimepointsOnly 1 time point where parents fill in questionnaire and a 24-hr recall will be conducted
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Serene Tan
- CONTACT for SCIENTIFIC QUERIES Serene Tan
- Sponsor/Initiator Friesland Campina
- Funding
(Source(s) of Monetary or Material Support)
Friesland Campina
- Publications
- Brief summaryFunctional gastrointestinal disorders are common in children and adults. These disorders are characterized by chronic or recurrent gastrointestinal symptoms in the absence of a recognized organic etiology. The prevalence of functional gastrointestinal disorders in infants and toddlers is largely unknown, especially in Asia. More prevalence information will increase understanding of health issues and may provide guidance of management. Therefore, this a one-time questionnaire based survey meant to assess the prevalence of functional gastrointestinal disorders in Vietnamese infants and toddlers is set up. It is a multicenter, observational study.
- Main changes (audit trail)
- RECORD25-sep-2018 - 6-okt-2018


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