An interventional study of Biogaia and Placebo in Functional Gastrointestinal Disorders and Infant Conditions, sponsored by Chulalongkorn University. Recruiting at 1 site in Thailand. Open to participants aged 3 Days to 1 Year, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by Chulalongkorn University · Not applicable, Interventional, and Treatment
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.
This is a randomized controlled trial study about the the efficacy of Lactobacillus reuteri DSM 1987 to prevent FGIDs in healthy infants and the effect to gut microbiota diversity. The incidence of FGIDs in Thai infant using Thai version of ROME IV questionnaire (authorized by Rome Foundation) for infant and toddler and the associated factors of FGIDs also evaluate.
Population: target and control populations are the healthy infants born at King Chulalongkorn Memorial Hospital, Bangkok, Thailand, and can come to follow up at the hospital at 1, 2, 4, and 12 months of age Inclusion criteria
Mothers have no previous probiotics use Methodology
Biological specimen collection Stool will be collected by rectal stimulation in each visit. The amount of >5 gm stool will be preserved in DNA and kept at -80 °C. All stool specimen will be processed the DNA extraction (DNA > 40 microlitre with concentration >50 ng/L). The DNA extraction for further amplification 16S rRNA using Illumina. The rest of the specimen will be kept up to 10 years for further evaluation.
Exclusion Criteria:
Limosilactobacillus reuteri DSM 17938 with sunflower oil and MCT oil were packed into a container. Infants will received 5 drops per day in the morning for 60 +/- 20 days
Dietary Supplement: Biogaia
Sunflower oit and MCT oil were paced into a container. Infants will received 5 drops per day in the morning for 60+/- 20 days
Other: Placebo
Biogaia is a probiotics product that contain Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil
Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil
Also known as: Sunflower oil + MCT oil
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 months
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)
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 age
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 year
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 months
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)
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 months
Fluid intake associated with functional gastrointestinal disorders in infants
type of milk (breastfeeding or formula or mixed) and amount (mL per kg body weight)
Time frame: at birth, 1 month, 2 months and 4 months and 1 year (5-time points)
Stress associated with functional gastrointestinal disorders in infants
stress in family (i.e divorce, family dept present as yes or no)
Time frame: at birth and 1 year
Antibiotics associated with functional gastrointestinal disorders in infants
antibiotics use (yes or no)
Time frame: at birth, 1 month, 2 months and 4 months and 1 year (5-time points)
Economic status associated with functional gastrointestinal disorders in infants
Economics status (income in baht)
Time frame: at birth and 1 year
Education of caregiver associated with functional gastrointestinal disorders in infants
Education (low, high)
Time frame: at birth and 1 year
Serious adverse effect during follow-up until end point
admission, cause of admission, treatment details (intravenous fluid, medication, oxygen supplementation)
Time frame: 1 month, 2 months, 4 months, 6 months, 9 months, 1 years
skin problems (seborrheic dermatitis, atopic dermatitis, nonspecific dermatitis)
patient oriented- Scoring atopic dermatitis (it is an application in phone to add the information of skin lesion by doctor or parent examination), examination and record the characteristics and location of skin lesion by doctors
Time frame: 1 month, 2 months, 4 months, 1 year
Plan to share: Undecided — The data were collected anonymous.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chulalongkorn University