RECRUITINGNA

Prevalence of FGIDs and Probiotics Study

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.

Sponsor

Chulalongkorn University

Enrollment

512 participants

Sites

1 locations

Start Date

March 2024

Completion

February 2026

Functional Gastrointestinal DisordersInfant ConditionsBiogaiaPlacebo

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

512

participants

Sites

locations

Duration

23 months

total trial span

Rate

pts/month needed

Mar 2024Month 25 of 23Feb 2026

100% of trial timeline elapsed

At 1 sites, each site needs to enroll approximately 22.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

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Primary Outcomes

The prevalence of functional gastrointestinal disorders in the treatment group

at birth, 1 month, 2 months, 4 months

Functional gastrointestinal disorders (colic, regurgitation, constipation, dyschazia and rumination) were assessed using the Thai version of Rome IV diagnostic questionnaire for neonates and toddlers

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

RECRUITINGNA

Prevalence of FGIDs and Probiotics Study

Sponsor

Chulalongkorn University

Enrollment

512 participants

Sites

1 locations

Start Date

March 2024

Completion

February 2026

Functional Gastrointestinal DisordersInfant ConditionsBiogaiaPlacebo

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

512

participants

Sites

locations

Duration

23 months

total trial span

Rate

pts/month needed

Mar 2024Month 25 of 23Feb 2026

100% of trial timeline elapsed

At 1 sites, each site needs to enroll approximately 22.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

The prevalence of functional gastrointestinal disorders in the treatment group

at birth, 1 month, 2 months, 4 months

Functional gastrointestinal disorders (colic, regurgitation, constipation, dyschazia and rumination) were assessed using the Thai version of Rome IV diagnostic questionnaire for neonates and toddlers

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

3 Days

Max Age

1 Year

Sex

all

Healthy Volunteers

Yes

View full 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

Prevalence of FGIDs and Probiotics Study

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Prevalence of FGIDs and Probiotics Study

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (1)