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.
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
- Conditions the study is for
- Respiratory Infection (for Example, Pneumonia, Bronchitis)
- 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.
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 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 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 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)
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
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
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.
- First posted3 Apr 2023
- Study start1 May 2023
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory Infection (for Example, Pneumonia, Bronchitis)Studies 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 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)
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
- Investigators
- Adli Ali, MD, Principal investigator, National University of Malaysia
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 41878569Uma 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 41561177Li 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Gut Microbiota by Probiotic in Children With Respiratory Symptoms
- ClinicalTrials.gov ID
- NCT05794815
- Acronym / sponsor ID
- UKMPPI/111/6/JEP-2023-074
- Keywords
- probiotic, respiratory tract infections, Bifidobacterium, children
- 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
- 1 May 2023 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 3 Apr 2023 (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 children with respiratory symptoms, among pre-school children in Malaysia aged >12 months old, <7 years old.
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.
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
- 12 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 children with respiratory tract infections upon administration of probiotic as assessed via pyrosequencing
Time frame: 12-weeks
Differences in microbiota abundance in fecal sample of children with respiratory tract infections upon administration o probiotic compared to placebo
3 secondary outcomes
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)
Time frame: 12-weeks
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)
Time frame: 12-weeks
Immunity profiles in children with respiratory tract infections 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 22 Aug 2023.
- Derived from this study: PubMed 41878569Uma 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.
- Derived from this study: PubMed 41561177Uma 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.
- Derived from this study: PubMed 40046755Li 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.
- 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.
Adli Ali, MD principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
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.