Prevalence of FGIDs and Probiotics Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-1
SponsorChulalongkorn University
About this trial
This is a study to evaluate the prevalence of FGIDs in infants using the Thai version of Rome IV diagnostic questionnaire for functional gastrointestinal disorders in infants and evaluate the efficacy of Limosilactobacillus reuteri DSM 17938 to prevent FGIDs in infants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy and term (GA 37-41 weeks) infants
Appropriate weight for age
APGAR score more than 8 at 10 minutes of life
Normal physical examination
Disqualifiers
not willing to anticipate in the study
cannot come to follow-up until 1 year of age
Trial design
Design model
Parallel
Treatments tested in this trial
Biogaia
Dietary supplementBiogaia is a probiotics product that contain Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil
Placebo
Other interventionLimosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil
Treatment groups
512 Participants
are divided into 2 treatment groupsGroup A: ProbioticsExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The prevalence of functional gastrointestinal disorders in the treatment group
Functional gastrointestinal disorders (colic, regurgitation, constipation, dyschazia and rumination) were assessed using the Thai version of Rome IV diagnostic questionnaire for neonates and toddlers
Time frame
at birth, 1 month, 2 months, 4 monthsSecondary outcomes
1
The prevalence of functional gastrointestinal disorders in the placebo group
Functional gastrointestinal disorders (include colic, regurgitation, constipation, dyschazia and rumination) were assessed using the Thai version of Rome IV diagnostic questionnaire for neonates and toddlers
Time frame
at birth, 1 month, 2 months, 4 months and 1 year (5-time points)2
The prevalence of functional gastrointestinal disorders in the treatment group
Functional gastrointestinal disorders (colic, regurgitation, constipation, dyschazia and rumination) were assessed using the Thai version of Rome IV diagnostic questionnaire for neonates and toddlers
Time frame
at 1 year of ageOther outcomes
1
Nutrition associated with functional gastrointestinal disorders in infants
Amount of food composition (carbohydrate, protein, lipid - present as gm per kg body weight)
Time frame
at 1 year2
Gut microbial profiles associated with functional gastrointestinal disorder in infants
Comparative metagenomic analysis of gut microbial profiles (diversity, relative abundance, species alteration) in fecal samples among different groups of infants
Time frame
at birth, 1 month, 2 months, and 4 months3
The sleep quality assessed by Brief Infant Sleep Revise Questionnaire of BISQR
The questionnaire has 33 items in 3 main categories (Infant sleep, parent perception and parent behavior). Scores on each subscale and the total score are scaled from 0 to 100. Higher score denote better sleep quality.
Time frame
at birth, 1 month, 2 months, 4 months and 1 year (5-time points)4
Stool metabolomic substances (i.e microbial conjugation of secondary bile acid, aminoacid) and the stool metabolites alteration
Fecal metabolomic substances (i.e microbial conjugation of secondary bile acid, aminoacid) were assesse using liquid chromatography-mass spectrometry (LC-MS), gas chromatography-mass spectrometry (GC-MS) and capillary electrophoresis-mass spectrometry (CE-MS)
Time frame
at birth, 1 month, 2 months and 4 monthsSponsors and contacts
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Source ClinicalTrials.gov