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Respiratory Infection (for Example, Pneumonia, Bronchitis)NCT05794815

Modulation of Gut Microbiota by Probiotic in Children With Respiratory Symptoms

A study testing Probiotic in people with Respiratory Infection (for Example, Pneumonia, Bronchitis), 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 The sponsor has not verified this record for over two years, so it may be out of date.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 children with respiratory symptoms, among pre-school children in Malaysia aged >12 months old, <7 years old. Read more about this study

Who is it for?
Ages 12 months to 7 years
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
1 May 2023to 1 May 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 12 months to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Preschool children (>12 months old, <7 years old).
  • Having respiratory symptoms (having at least two of the following signs and symptoms: fever (even if only reported not measured), nasal obstruction, chills, sore throat, headache, cough, runny nose, olfactory disturbances, or taste disturbances; Pucarelli-Lebreiro et al., 2022).
  • Healthy with current weight of P20-P80 percentile chart of children
  • Infant formula powder does not contain probiotics; prebiotics FOS is not allowed, GOS <2g/ 100g is allowed
  • Willing to commit throughout the experiment

Who cannot join

  • Long term medication >6 months for any diseases
  • Deformity
  • Mothers with metabolic and/or chronic diseases
  • Current or previous diseases, conditions or interventions that may interfere with the study (such as tolerance and/or growth and development), such as gastrointestinal malformations, chronic diarrhea, malabsorption syndromes, malnutrition, congenital immunodeficiency or surgery
  • Oral antibiotics within 2 weeks before the intervention
  • Nutritional supplements containing probiotics and prebiotics (except infant formula) within 2 weeks before the intervention
Show all 10Show fewer
  • Foods for special medical purposes or non-standard formula powders for lactose intolerance and galactosemia
  • Probiotic allergies or possible food allergies (milk, etc.)
  • Participated in other clinical studies 4 weeks before the intervention
  • Unwilling to participate for any particular reason

Trial locations and contacts

1 site in 1 country.

Min Tze Liong, PhD contact

6046532114

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 children with respiratory symptoms, among pre-school children in Malaysia aged >12 months old, <7 years old.

Read the detailed description

Probiotic can be defined as "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.

Respiratory illnesses are the most common acute diseases in children where no virtually effective treatments or prophylaxes are available for these infections. Probiotics on the other hand have gained increasing evidences as an effective therapy in preventing respiratory tract infections. Children attending day care are especially at risk for acquiring respiratory illness, as close physical contact among children in day care favour the transmission of infectious diseases. When studying children receiving either probiotic in milk and control milk, the number of absences from day care because of illness is significantly lesser in probiotic group when compared with control group. In addition, children in the probiotic group had fewer respiratory tract infections with complications (otitis media, sinusitis, bronchitis and pneumonia) and less prescribed antibiotic treatments. The time without respiratory symptoms was also significantly longer in the probiotic group compared with the control group. When the effects of probiotics were studied on nasopharyngeal carriage of bacterial pathogens, the number of human bocavirus was reduced significantly in the nasopharynx of these children, indicating that probiotics may be more effective against respiratory tract infections of viral origin. While the precise mechanisms of using probiotics in management of respiratory infections are largely unknown, speculations include: probiotics compete against pathogens; increase the barrier function in respiratory epithelium; immunostimulatory effects by enhancing cellular immunity with increased activity of natural killer cells and macrophages in airways. Hence, probiotics may offer safe means of reducing the risk of early respiratory related illnesses, common cold and antibiotic use, and the risk of recurrent respiratory infections, thereby represent a simple, safe, effective, available and affordable method for preventing respiratory infections in children.

In worldwide, it is estimated that 5.2 million of children under five of age die every year due to preventable disease such as diarrhea, malaria and pneumonia. 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. One of the most common gastrointestinal disorders in young children, is diarrhea. Diarrhea is commonly defined as three or more loose or watery stools in the last 24 hours. For clinical studies employing oral administration of probiotics, the probiotics were administered directly to the participants or mixed with a variety of fluids and foods. In studies on probiotic prevention of acute diarrhea in daycare centres worldwide, probiotics tested such as Lactobacillus GG, Bifidobacterium lactis (alone or in combination with Streptococcus thermophiles), and Lactobacillus reuteri, Lactobacillus casei and Lactobacillus acidophilus showed a clear evidence of efficacy to reduce diarrhea-related symptoms in a strain-dependent and dose-dependent manner. Probiotics administration reduces duration of diarrhea, indicating the efficacy of probiotics not only in preventing occurrence of diarrhea, as well as to treat episodes of diarrhea. 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 the probiotics treatment of acute rotavirus diarrhoea. The rationale for using probiotics in infectious diarrhoea 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, and increasing specific and non-specific immune responses. Probiotics reduced infectious diarrhoea in children and adults in various settings but a mechanism common to most probiotics, for example, colonization resistance, is effective 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 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 preventing diarrhea and/or respiratory-related illness prevalence in young children.

Probiotic (Bifidobacterium infantis YLGB-1496) adheres to probiotic properties such as excellent tolerance to gastric acid, intestinal fluid and bile salt of the digestive system. Both probiotic and placebo products are manufactured under HACCP conditions. All products do not contain any animal-origin ingredients. The probiotic product contains probiotic and carrier while placebo contains only carrier. Sachets of products containing probiotic and placebo appear as light yellow powder. Both probiotic and placebo products are kept at storage temperature range below 30oC according to the condition recommended by the manufacturer.

Being tested
Probiotic, Placebo
Keywords
probiotic, respiratory tract infections, Bifidobacterium, children
Medical subject headings
Respiratory Tract Infections, Pneumonia, Bronchitis

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 NCT05794815
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 children with respiratory tract infections upon administration of probiotic as assessed via pyrosequencing

    Differences in microbiota abundance in fecal sample of children with respiratory tract infections upon administration o probiotic compared to placebo

    Measured: 12-weeks

Secondary outcomes (3)
  1. Clinical respiratory symptoms duration and frequency in children with respiratory tract infections 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 children on probiotic or placebo after 12-weeks, via the use of questionnaire.

    Measured: 12-weeks

  2. Clinical gastrointestinal symptoms in children with respiratory tract infections 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 of children upon administration of probiotic compared to placebo

    Measured: 12-weeks

  3. Immunity profiles in children with respiratory tract infections 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) of children 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 posted3 Apr 2023
  2. Study start1 May 2023
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2026 (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 N/A
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
NCT05794815
Sponsor's protocol ID
UKMPPI/111/6/JEP-2023-074
Status last verified
Aug 2023
First submitted
20 Mar 2023
Last updated
22 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Uma Mageswary M, Hanglian L, Li P, Richmond RV, Azianey Y, Tan JS, Liong MT, Ali A, Vejayantheran M, Hua J, Jian H, Abd Hamid IJ, Taib F, Zhang Y. Probiotic improves respiratory and gastrointestinal health, immune homeostasis, and gut microbiota composition in infants: a randomized controlled trial. Front Nutr. 2026 Mar 9;13:1746679. doi: 10.3389/fnut.2026.1746679. eCollection 2026.

    PubMed 41878569
  • Uma Mageswary M, Li P, Richmond RV, Azianey Y, Abd Hamid IJ, Taib F, Liong MT, Ali A, Tan JS, Zhang Y. Clinical benefits of Bifidobacterium infantis YLGB-1496 in modulating gut microbiota and immunity in young children. Front Nutr. 2026 Jan 5;12:1713135. doi: 10.3389/fnut.2025.1713135. eCollection 2025.

    PubMed 41561177
  • Li P, Mageswary U, Ali A, Taib F, Koo TH, Yusof A, Jiang H, Lan H, Hung W, Liong MT, Zhang Y. Clinical effects of Bifidobacterium Longum Subsp. Infantis YLGB-1496 on children with respiratory symptoms. Front Nutr. 2025 Feb 19;12:1537610. doi: 10.3389/fnut.2025.1537610. eCollection 2025.

    PubMed 40046755

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic in people with Respiratory Infection (for Example, Pneumonia, Bronchitis), 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 5 inclusion and 10 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 22 Aug 2023. 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.

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 children with respiratory tract infections 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?

On the ClinicalTrials.gov record for NCT05794815, which also lists 3 linked publications.

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 22 Aug 2023.

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