Prevalence of FGIDs and Probiotics Study (PROOF)

Chulalongkorn University

Status: Enrolling

Conditions: Functional Gastrointestinal Disorders; Infant Conditions

Treatments: Other: Placebo; Dietary Supplement: Biogaia

Study type: Interventional

Funder types: Other

Identifiers

NCT06309199

0855/66

Details and patient eligibility

About

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.

Full 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.

Enrollment: 512 estimated patients

Sex: All

Ages: 3 days to 1 year old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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512 participants in 2 patient groups, including a placebo group

Probiotics

Experimental group

Description:

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

Treatment:

Dietary Supplement: Biogaia

Placebo

Placebo Comparator group

Description:

Sunflower oit and MCT oil were paced into a container. Infants will received 5 drops per day in the morning for 60+/- 20 days

Treatment:

Other: Placebo