Prevalence of FGIDs and Probiotics Study

NCT06309199 | Recruiting

• 1 other identifier: 0855/66
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Gastrointestinal Disorders; Infant Conditions

Keywords

functional gastrointestinal disorder; colic; regurgitation; constipation; infant; prevalence

Outcome Measures

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

  at birth, 1 month, 2 months, 4 months

Secondary Outcomes (2)

• The prevalence of functional gastrointestinal disorders in the placebo group

  at birth, 1 month, 2 months, 4 months and 1 year (5-time points)

• The prevalence of functional gastrointestinal disorders in the treatment group

  at 1 year of age

Other Outcomes (11)

• Nutrition associated with functional gastrointestinal disorders in infants

  at 1 year

• Gut microbial profiles associated with functional gastrointestinal disorder in infants

  at birth, 1 month, 2 months, and 4 months

• The sleep quality assessed by Brief Infant Sleep Revise Questionnaire of BISQR

  at birth, 1 month, 2 months, 4 months and 1 year (5-time points)

Study Arms (2)

Probiotics

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Biogaia DIETARY_SUPPLEMENT

Biogaia is a probiotics product that contain Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil

Probiotics

Placebo OTHER

Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil

Also known as: Sunflower oil + MCT oil

Placebo

Eligibility Criteria

• Age: 3 Days - 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Maha Chakri Sirindhorn Clinical Research Center (Chula CRC)

Bangkok, Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Diseases; Colic; Gastroesophageal Reflux; Constipation

Interventions

Sunflower Oil

Condition Hierarchy (Ancestors)

Digestive System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Yong Poovorawan, MD

  Center of Excellence in Clinical Virology

  STUDY DIRECTOR

Central Study Contacts

Palittiya Sintusek, PhD

CONTACT

+66818288082; palittiya.s@chula.ac.th

Sittichoke Prachuapthunyachart, MD

CONTACT

+66829740649; sittichoke.p@chula.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: These 2 groups was assigned using computer generate with block of 4 and ratio 1:1. The intervention and placebo were prepare in the same container with the same color, odor and blinded to investigators, participants and guardians.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Center of Excellence in Thai Pediatric Gastroenterology, Hepatology and Immunology

Model Details: Intervention group received probiotics Control group received sunflower and MCT oil

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: March 13, 2024
• Study Start: March 14, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2024-08

Locations

TH (1)