Functional Gastrointestinal DisordersPROOFNCT06309199
Prevalence of FGIDs and Probiotics Study
A study testing Biogaia in people with Functional Gastrointestinal Disorders and Infant Conditions, run by Chulalongkorn University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 3 days to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Functional Gastrointestinal Disorders, Infant Conditions
- What is being tested?
- Biogaia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 512 participants
- Where
- 1 siteThailand
- Study dates
- 14 Mar 2024to Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- not willing to anticipate in the study
- cannot come to follow-up until 1 year of age
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Maha Chakri Sirindhorn Clinical Research Center (Chula CRC)
Bangkok, Bangkok, 10330
02 251 6704
About this study
Official title: Center of Excellence in Thai Pediatric Gastroenterology, Hepatology and Immunology
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.
Read the detailed 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
- 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 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.
- Being tested
- Biogaia, Placebo
- Keywords
- functional gastrointestinal disorder, colic, regurgitation, constipation, infant, prevalence
- Medical subject headings
- Gastrointestinal Diseases, Colic, Gastroesophageal Reflux, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiogaiaDietary supplement
Biogaia is a probiotics product that contain Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil
PlaceboOther
Also called Sunflower oil + MCT oil
Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at birth, 1 month, 2 months, 4 months
Secondary outcomes (2)
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
Measured: at birth, 1 month, 2 months, 4 months and 1 year (5-time points)
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
Measured: at 1 year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start14 Mar 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group received probiotics Control group received sunflower and MCT oil
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Palittiya Sintusek, MD, Chulalongkorn University
- Investigators
- Yong Poovorawan, MD, Study director, Center of Excellence in Clinical Virology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309199
- Sponsor's protocol ID
- 0855/66
- Acronym
- PROOF
- Status last verified
- Aug 2024
- First submitted
- 12 Feb 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data were collected anonymous.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Center of Excellence in Thai Pediatric Gastroenterology, Hepatology and Immunology
- ClinicalTrials.gov ID
- NCT06309199
- Acronym / sponsor ID
- PROOF / 0855/66
- Keywords
- functional gastrointestinal disorder, colic, regurgitation, constipation, infant, prevalence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Intervention group received probiotics Control group received sunflower and MCT oil
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: BiogaiaLimosilactobacillus 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 |
| Placebo | Placebo comparator | Other: PlaceboSunflower oit and MCT oil were paced into a container. Infants will received 5 drops per day in the morning for 60+/- 20 days |
Who may qualify
- Ages
- 3 days to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- not willing to anticipate in the study
- cannot come to follow-up until 1 year of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiogaiaBiogaia is a probiotics product that contain Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil | Dietary supplement | Probiotics |
| PlaceboAlso: Sunflower oil + MCT oilLimosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil | Other | Placebo |
Primary outcome
The prevalence of functional gastrointestinal disorders in the treatment group
Time frame: 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
2 secondary outcomes
The prevalence of functional gastrointestinal disorders in the placebo group
Time frame: at birth, 1 month, 2 months, 4 months and 1 year (5-time points)
The prevalence of functional gastrointestinal disorders in the treatment group
Time frame: at 1 year of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: Undecided. The data were collected anonymous.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Poovorawan, MD study director
Center of Excellence in Clinical Virology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biogaia in people with Functional Gastrointestinal Disorders and Infant Conditions, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Palittiya Sintusek, PhD (+66818288082, palittiya.s@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of functional gastrointestinal disorders in the treatment group (time frame: at birth, 1 month, 2 months, 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.