Clinical trial NCT06309199: Prevalence of FGIDs and Probiotics Study
Official title: Center of Excellence in Thai Pediatric Gastroenterology, Hepatology and Immunology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Infant Conditions
Keywords: functional gastrointestinal disorder
colic
regurgitation
constipation
infant
prevalence
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 512
Sex: ALL
Minimum age (years): 3
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group received probiotics Control group received sunflower and MCT oil
Primary purpose: TREATMENT

Brief summary: 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
   * 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.

Eligibility criteria: 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

Exclusion Criteria:

1. not willing to anticipate in the study
2. cannot come to follow-up until 1 year of age

Primary outcomes:
measure: The prevalence of functional gastrointestinal disorders in the treatment group
timeFrame: at birth, 1 month, 2 months, 4 months and 1 year (5-time points)
Secondary outcomes:
measure: The prevalence of functional gastrointestinal disorders in the placebo group
timeFrame: at birth, 1 month, 2 months, 4 months and 1 year (5-time points)
Other outcomes:
measure: Nutrition associated with functional gastrointestinal disorders in infants
timeFrame: at 1 year
measure: Gut microbial profiles associated with functional gastrointestinal disorder in infants
timeFrame: at birth, 1 month, 2 months, and 4 months
measure: The sleep quality assessed by Brief Infant Sleep Revise Questionnaire of BISQR
timeFrame: at birth, 1 month, 2 months, 4 months and 1 year (5-time points)
measure: Stool metabolomic substances (i.e microbial conjugation of secondary bile acid, aminoacid) and the stool metabolites alteration
timeFrame: at birth, 1 month, 2 months and 4 months
measure: Fluid intake associated with functional gastrointestinal disorders in infants
timeFrame: at birth, 1 month, 2 months and 4 months and 1 year (5-time points)
measure: Stress associated with functional gastrointestinal disorders in infants
timeFrame: at birth and 1 year
measure: Antibiotics associated with functional gastrointestinal disorders in infants
timeFrame: at birth, 1 month, 2 months and 4 months and 1 year (5-time points)
measure: Economic status associated with functional gastrointestinal disorders in infants
timeFrame: at birth and 1 year
measure: Education of caregiver associated with functional gastrointestinal disorders in infants
timeFrame: at birth and 1 year
measure: Serious adverse effect during follow-up until end point
timeFrame: 1 month, 2 months, 4 months, 6 months, 9 months, 1 years
measure: skin problems (seborrheic dermatitis, atopic dermatitis, nonspecific dermatitis)
timeFrame: 1 month, 2 months, 4 months, 1 year
Locations:
city: Bangkok
country: Thailand
facility: Maha Chakri Sirindhorn Clinical Research Center (Chula CRC)
Study officials:
affiliation: Center of Excellence in Clinical Virology
name: Yong Poovorawan, MD
role: STUDY_DIRECTOR
References: