Prevalence of FGIDs and Probiotics Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biogaia, Placebo.
- Who it may be relevant to
- Registry conditions: Functional Gastrointestinal Disorders, Infant Conditions. Basic parameters: 3 Days — 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Center of Excellence in Thai Pediatric Gastroenterology, Hepatology and Immunology
Overview
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.
Detailed description
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
1. Healthy and term (GA 37-41 weeks) infants 2. Appropriate weight for age 3. APGAR score more than 8 at 10 minutes of life 4. Normal physical examination 5. Mothers have no previous probiotics use Methodology
* Participants were double-blinded randomized using computer generation in block of four * Target population were received Limosilactobacillus reuteri DSM 17938 5 drops (0.185 mL) per day for 60 days * Control population were received mixture of sunflower oil and MCT oil 5 drop (0.185 mL) per day for 60 days * There were 5 visits at birth, 1, 2, 4, 12 months of life: the demographic data/Rome IV questionnaire for FGIDs in infant and associated factors with FGIDs record, physical examination and stool collection The study will be analyzed (open the randomized group) after all participants complete the 4-month follow-up period * Research assistance will telephone to them to take the Rome IV questionnaire for FGIDs at 3, 6, 9 months of life
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.
Interventions
- Dietary supplement Biogaia
Biogaia is a probiotics product that contain Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil - Other Placebo
Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil
Primary outcome measures
- The prevalence of functional gastrointestinal disorders in the treatment group [Time frame: at birth, 1 month, 2 months, 4 months]
Secondary outcome measures (2)
- The prevalence of functional gastrointestinal disorders in the placebo group [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 [Time frame: at 1 year of age]
Eligibility criteria
Inclusion criteria
- 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
- Mothers have no previous probiotics use
Exclusion criteria
- not willing to anticipate in the study
- cannot come to follow-up until 1 year of age
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- Maha Chakri Sirindhorn Clinical Research Center (Chula CRC) — Bangkok
Identifiers
NCT: NCT06309199 · 0855/66