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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Min Tze Liong, PhD contact

604 653 2114

mintze.liong@usm.my

Malaysia1 site, 1 recruiting
  • UKM Medical Centre

    Cheras, Kuala Lumpur, 56000

    Adli Adli, MD, 603 8921 5555, adli.ali@ppukm.ukm.edu.my

    Fahisham Taib, MD

    Recruiting

Other trials in Malaysia

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.

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 groups in NCT06474234
Study groupRoleWhat they receive
ProbioticExperimentalBifidobacterium infantis YLGB-1496 at 1x10 log CFU/day for 12 weeks
Receives: Dietary Supplement: Probiotic
PlaceboPlacebo comparatorIntervention 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted25 Jun 2024
  2. Study start29 May 2024
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

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)
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

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.

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