Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
512 participants
INTERVENTIONAL
2024-03-14
2026-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
The intervention and placebo were prepare in the same container with the same color, odor and blinded to investigators, participants and guardians.
Study Groups
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Probiotics
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
Biogaia
Biogaia is a probiotics product that contain Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil
Placebo
Sunflower oit and MCT oil were paced into a container. Infants will received 5 drops per day in the morning for 60+/- 20 days
Placebo
Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil
Interventions
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Biogaia
Biogaia is a probiotics product that contain Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil
Placebo
Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. cannot come to follow-up until 1 year of age
3 Days
1 Year
ALL
Yes
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Palittiya Sintusek, MD
Director, Head of Center of Excellence in Thai Pediatric Gastroenterology, Hepatology and Immunology
Principal Investigators
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Yong Poovorawan, MD
Role: STUDY_DIRECTOR
Center of Excellence in Clinical Virology
Locations
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Maha Chakri Sirindhorn Clinical Research Center (Chula CRC)
Bangkok, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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0855/66
Identifier Type: -
Identifier Source: org_study_id
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