Prevalence of FGIDs and Probiotics Study

Functional Gastrointestinal Disorders Clinical Trial

— PROOF  

Official title:

Center of Excellence in Thai Pediatric Gastroenterology, Hepatology and Immunology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06309199
• Other study ID #: 0855/66
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: Chulalongkorn University
• Contact: Palittiya Sintusek, PhD
• Phone: +66818288082
• Email: palittiya.s[@]chula.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 512
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Days to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Infant Conditions

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nutrition associated with functional gastrointestinal disorders in infants	Amount of food composition (carbohydrate, protein, lipid - present as gm per kg body weight)	at 1 year
Other	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	at birth, 2 months, and 4 months
Other	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.	at birth, 1 month, 2 months, 4 months and 1 year (5-time points)
Other	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)	at birth, 2 months and 4 months
Other	Fluid intake associated with functional gastrointestinal disorders in infants	type of milk (breastfeeding or formula or mixed) and amount (mL per kg body weight)	at birth, 1 month, 2 months and 4 months and 1 year (5-time points)
Other	Stress associated with functional gastrointestinal disorders in infants	stress in family (i.e divorce, family dept present as yes or no)	at birth and 1 year
Other	Antibiotics associated with functional gastrointestinal disorders in infants	antibiotics use (yes or no)	at birth, 1 month, 2 months and 4 months and 1 year (5-time points)
Other	Economic status associated with functional gastrointestinal disorders in infants	Economics status (income in baht)	at birth and 1 year
Other	Education of caregiver associated with functional gastrointestinal disorders in infants	Education (low, high)	at birth and 1 year
Primary	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	at birth, 1 month, 2 months, 4 months and 1 year (5-time points)
Secondary	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	at birth, 1 month, 2 months, 4 months and 1 year (5-time points)