Generally HealthyPhase 2NCT06474234
Modulation of Gut Microbiota by Probiotic in Children
A Phase 2 study testing Probiotic in people with Generally Healthy, run by Min-Tze LIONG at 1 site in Malaysia.
Trial summary
This project aims to study the benefits of probiotics namely Bifidobacterium infantis YLGB-1496 in modulating gut microbiota of healthy children, among pre-school children in Malaysia <7 years old. Read more about this study
- Who is it for?
- Ages 1 month to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Generally Healthy
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteMalaysia
- Study dates
- 29 May 2024to 30 Jun 2025
- Phase
- Phase 2
- 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 1 month to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preschool children (<7 years old)
- Born full-term (≥37 weeks delivered)
- In generally good health as determined by the investigator
Who cannot join
- Had taken probiotics or prebiotics within past 4-weeks
- Had taken milk powder or supplements containing probiotics within past 4-weeks
- History of using antibiotic within past 4-weeks
- Suffering from serious acute or chronic diseases (cardiovascular disease, gastrointestinal disease, endocrine disease, immune system disease, metabolic disease, etc.)
- Using other drugs that may interfere with the experimental results
- Participated in other experimental trials less than 8-weeks prior to this study
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
UKM Medical Centre
Cheras, Kuala Lumpur, 56000
Adli Adli, MD, 603 8921 5555, adli.ali@ppukm.ukm.edu.my
Fahisham Taib, MD
About this study
This project aims to study the benefits of probiotics namely Bifidobacterium infantis YLGB-1496 in modulating gut microbiota of healthy children, among pre-school children in Malaysia <7 years old.
Read the detailed description
Probiotic is live microorganisms that grant health effects to the host if consumed in sufficient amounts. Probiotic bacteria, which beneficially affect the host by improving the intestinal microbial balance, may affect the immune response, thus boosting the body system to combat against diseases.
One of the most common gastrointestinal disorders in young children, is diarrhea. In worldwide, it was reported by WHO that 5.2 million of children under five of age die every year due to preventable diseases involving gut health such as diarrhea. Up to date, diarrhea still remains as global health issues, even in developing countries, with 1 million of children deaths reported to be attributed to diarrhea. In Malaysia, reported cases of diarrhea and acute gastroenteritis have been observed to occur throughout the year, with rotavirus-associated diarrhea being the most prevalently identified gastrointestinal disorder.
Probiotics have a been administered to children for the maintenance of gut health and to combat gastrointestinal disorders. In children, probiotics are consumed directly or mixed with a variety of fluids and foods. Probiotics such as Lactobacillus GG, Bifidobacterium lactis (alone or in combination with Streptococcus thermophiles), and Lactobacillus reuteri, Lactobacillus casei and Lactobacillus acidophilus have been shown to reduce gastrointestinal-related symptoms in a strain-dependent and dose-dependent manner. In a review involving 15 clinical studies, participants who were on probiotics administration were less likely to have gastrointestinal disorders, indicating the efficacy of probiotics in children. The effect of probiotics Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum and Saccharomyces boulardii also showed decreased time of vomiting in the intervention groups as compared with controls during acute rotavirus diarrhoea. The rationale for using probiotics in gut disorders is that they act against enteric pathogens by competing for available nutrients and binding sites, making the gut contents acid, producing a variety of chemicals, increasing specific and non-specific immune responses, and colonization resistance against a wide range of gut pathogens.
Probiotic bacteria, which beneficially affect the host by improving the intestinal microbial balance, may affect the immune response, thus boosting the body system to combat against diseases. Probiotics have been studied extensively for their effects in preventing and treating a multitude of conditions, including the treatment of lactose intolerance, traveller's diarrhoea and the prevention and treatment of nosocomial diarrhoea. In acute diarrhoea, a reduction in the frequency of diarrhoeal symptoms has been reported in adults and children treated with probiotics. Among the beneficial microbes, Bifidobacterium is one of the best-known probiotic genus in the world, and it is widely applied in the dairy industry as a probiotic. Evidences from more than 100 scientific publications based on in vitro, in vivo, and clinical studies and long consumption history support the safety and health benefits of Bifidobacterium strains. The ingestion of yogurt fortified with B. longum reduced harmful bacteria such as Enterobacteriaceae, Streptococcus and C. perfringens, while at the same time alter the microbiota gut profile of volunteers with a significant increase of beneficial microbes Bifidobacterium and Lactobacillus species. Additionally, putrefactive substances in the intestinal environment were also reduced in the presence of the probiotic supplement. Such findings suggest that Bifidobacterium strains are safe and could be used further to evaluate its effect in modulating gut health of children.
Our previous study involving probiotic (Bifidobacterium infantis YLGB-1496) in children with respiratory symptoms (human ethics approval number JEP-2023-074) shows good compliance without any adverse effects. Preliminary clinical assessments have also shown positive feedbacks from parents and guardians. Thus, the aim of the present study is to evaluate the same objectives as before, in healthy children.
- Conditions
- Generally Healthy
- Being tested
- Probiotic, Placebo
- Keywords
- Bifidobacterium, probiotic, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Bifidobacterium infantis YLGB-1496 at 1x10 log CFU/day for 12 weeks
PlaceboDietary supplement
Intervention consists of daily administration of 2g of maltodextrin, administered daily for 12-weeks)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Bifidobacterium infantis YLGB-1496 at 1x10 log CFU/day for 12 weeks Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Intervention consists of daily administration of 2g of maltodextrin, administered daily for 12-weeks) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota profiles of fecal samples in generally healthy children upon administration of probiotic as assessed via pyrosequencing
Differences in microbiota abundance in fecal sample of generally healthy children upon administration o probiotic compared to placebo
Measured: 12-weeks
Secondary outcomes (3)
Clinical respiratory symptoms duration and frequency in generally healthy children upon administration of probiotic as assessed using the Monthly Health Questionnaire (as used in ClinicalTrials.gov (identifier number NCT02434042)
Changes in duration and frequency of respiratory illnesses symptoms from generally healthy children on probiotic or placebo after 12-weeks, via the use of questionnaire.
Measured: 12-weeks
Clinical gastrointestinal symptoms in generally healthy children upon administration of probiotic as assessed using the Monthly Gastrointestinal Questionnaire as used in ClinicalTrials.gov (identifier number NCT02434042)
Differences in duration and frequency of gastrointestinal symptoms upon administration of probiotic compared to placebo
Measured: 12-weeks
Immunity profiles in generally healthy children upon administration of probiotic via the use of oral swabs
Differences in concentrations of proteins such as interleukins (IL-10, IL-4, IL-6, Tumour Necrosis Factor-alpha, Interferon gamma) in swab samples (ug/mL) upon administration of probiotic compared to placebo
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start29 May 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generally HealthyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min-Tze LIONG
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Malaysia
- Responsible party
- Sponsor-investigator, Min-Tze LIONG, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474234
- Sponsor's protocol ID
- JEP-2023-972
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Gut Microbiota by Probiotic in Children
- ClinicalTrials.gov ID
- NCT06474234
- Acronym / sponsor ID
- JEP-2023-972
- Conditions
- Generally Healthy
- Keywords
- Bifidobacterium, probiotic, children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Min-Tze LIONGUniversity, hospital or other
- Collaborators
- National University of Malaysia
- Study start
- 29 May 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 25 Jun 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 project aims to study the benefits of probiotics namely Bifidobacterium infantis YLGB-1496 in modulating gut microbiota of healthy children, among pre-school children in Malaysia <7 years old.
Detailed description
Probiotic is live microorganisms that grant health effects to the host if consumed in sufficient amounts. Probiotic bacteria, which beneficially affect the host by improving the intestinal microbial balance, may affect the immune response, thus boosting the body system to combat against diseases.
One of the most common gastrointestinal disorders in young children, is diarrhea. In worldwide, it was reported by WHO that 5.2 million of children under five of age die every year due to preventable diseases involving gut health such as diarrhea. Up to date, diarrhea still remains as global health issues, even in developing countries, with 1 million of children deaths reported to be attributed to diarrhea. In Malaysia, reported cases of diarrhea and acute gastroenteritis have been observed to occur throughout the year, with rotavirus-associated diarrhea being the most prevalently identified gastrointestinal disorder.
Probiotics have a been administered to children for the maintenance of gut health and to combat gastrointestinal disorders. In children, probiotics are consumed directly or mixed with a variety of fluids and foods. Probiotics such as Lactobacillus GG, Bifidobacterium lactis (alone or in combination with Streptococcus thermophiles), and Lactobacillus reuteri, Lactobacillus casei and Lactobacillus acidophilus have been shown to reduce gastrointestinal-related symptoms in a strain-dependent and dose-dependent manner. In a review involving 15 clinical studies, participants who were on probiotics administration were less likely to have gastrointestinal disorders, indicating the efficacy of probiotics in children. The effect of probiotics Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum and Saccharomyces boulardii also showed decreased time of vomiting in the intervention groups as compared with controls during acute rotavirus diarrhoea. The rationale for using probiotics in gut disorders is that they act against enteric pathogens by competing for available nutrients and binding sites, making the gut contents acid, producing a variety of chemicals, increasing specific and non-specific immune responses, and colonization resistance against a wide range of gut pathogens.
Probiotic bacteria, which beneficially affect the host by improving the intestinal microbial balance, may affect the immune response, thus boosting the body system to combat against diseases. Probiotics have been studied extensively for their effects in preventing and treating a multitude of conditions, including the treatment of lactose intolerance, traveller's diarrhoea and the prevention and treatment of nosocomial diarrhoea. In acute diarrhoea, a reduction in the frequency of diarrhoeal symptoms has been reported in adults and children treated with probiotics. Among the beneficial microbes, Bifidobacterium is one of the best-known probiotic genus in the world, and it is widely applied in the dairy industry as a probiotic. Evidences from more than 100 scientific publications based on in vitro, in vivo, and clinical studies and long consumption history support the safety and health benefits of Bifidobacterium strains. The ingestion of yogurt fortified with B. longum reduced harmful bacteria such as Enterobacteriaceae, Streptococcus and C. perfringens, while at the same time alter the microbiota gut profile of volunteers with a significant increase of beneficial microbes Bifidobacterium and Lactobacillus species. Additionally, putrefactive substances in the intestinal environment were also reduced in the presence of the probiotic supplement. Such findings suggest that Bifidobacterium strains are safe and could be used further to evaluate its effect in modulating gut health of children.
Our previous study involving probiotic (Bifidobacterium infantis YLGB-1496) in children with respiratory symptoms (human ethics approval number JEP-2023-074) shows good compliance without any adverse effects. Preliminary clinical assessments have also shown positive feedbacks from parents and guardians. Thus, the aim of the present study is to evaluate the same objectives as before, in healthy children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticBifidobacterium infantis YLGB-1496 at 1x10 log CFU/day for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIntervention consists of daily administration of 2g of maltodextrin, administered daily for 12-weeks) |
Who may qualify
- Ages
- 1 month to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preschool children (<7 years old)
- Born full-term (≥37 weeks delivered)
- In generally good health as determined by the investigator
Key exclusion criteria (6 listed)
- Had taken probiotics or prebiotics within past 4-weeks
- Had taken milk powder or supplements containing probiotics within past 4-weeks
- History of using antibiotic within past 4-weeks
- Suffering from serious acute or chronic diseases (cardiovascular disease, gastrointestinal disease, endocrine disease, immune system disease, metabolic disease, etc.)
- Using other drugs that may interfere with the experimental results
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 |
|---|---|---|
| ProbioticBifidobacterium infantis YLGB-1496 at 1x10 log CFU/day for 12 weeks | Dietary supplement | Probiotic |
| PlaceboIntervention consists of daily administration of 2g of maltodextrin, administered daily for 12-weeks) | Dietary supplement | Placebo |
Primary outcome
Microbiota profiles of fecal samples in generally healthy children upon administration of probiotic as assessed via pyrosequencing
Time frame: 12-weeks
Differences in microbiota abundance in fecal sample of generally healthy children upon administration o probiotic compared to placebo
3 secondary outcomes
Clinical respiratory symptoms duration and frequency in generally healthy children upon administration of probiotic as assessed using the Monthly Health Questionnaire (as used in ClinicalTrials.gov (identifier number NCT02434042)
Time frame: 12-weeks
Clinical gastrointestinal symptoms in generally healthy children upon administration of probiotic as assessed using the Monthly Gastrointestinal Questionnaire as used in ClinicalTrials.gov (identifier number NCT02434042)
Time frame: 12-weeks
Immunity profiles in generally healthy children upon administration of probiotic via the use of oral swabs
Time frame: 12-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Generally Healthy, run by Min-Tze LIONG at 1 site in Malaysia.
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 3 inclusion and 6 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 25 Jun 2024. 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 Malaysia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Adli Ali, MD (603 8921 5555, adli.ali@ppukm.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota profiles of fecal samples in generally healthy children upon administration of probiotic as assessed via pyrosequencing (time frame: 12-weeks). 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 25 Jun 2024.