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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03608735
Recruitment Status : Completed
First Posted : August 1, 2018
Last Update Posted : January 6, 2020
Sponsor:
Collaborator:
ObvioHealth
Information provided by (Responsible Party):
Danone Asia Pacific Holdings Pte, Ltd.

Study Description
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Brief Summary:
Prevalence and impact of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand

Condition or disease
Functional Gastrointestinal Disorders

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
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Study Type : Observational
Actual Enrollment : 7908 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Prevalence of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand
Actual Study Start Date : November 7, 2018
Actual Primary Completion Date : January 15, 2019
Actual Study Completion Date : September 19, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. To measure Quality of Life using modified Pediatric Quality of Life Inventory™ [ Time Frame: 1 day ]
    Pediatric Quality of Life Inventory of the parents/caretakers and the family (using modified PedsQL™ Family Impact Module, Scale 0 -144)


Other Outcome Measures:
  1. 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) [ Time Frame: 1 day ]
    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

  2. 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) [ Time Frame: 1 day ]
    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

  3. 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) [ Time Frame: 1 day ]
    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

  4. 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) [ Time Frame: 1 day ]
    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

  5. 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) [ Time Frame: 1 day ]
    Visit to doctor, healthcare professional, clinic, and/or hospital for FGIDs and related signs and symptoms


Eligibility Criteria
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Ages Eligible for Study:   2 Months to 19 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
otherwise healthy infants and toddlers aged 2 to 19 months
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608735


Locations
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Thailand
Khon Kaen University
Khon Kaen, Thailand
Sponsors and Collaborators
Danone Asia Pacific Holdings Pte, Ltd.
ObvioHealth
Investigators
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Principal Investigator: Busara Charoenwat, MBBS Khon Kaen University
More Information
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Responsible Party: Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier: NCT03608735    
Other Study ID Numbers: EBB17GC17070_1 / OBVIO-DAN-004
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases