Respiratory Infection (for Example, Pneumonia, Bronchitis)NCT04122495
Treatment of Upper and Lower Respiratory Tract Infections in Young Children Using Probiotic
A study testing Probiotic in people with Respiratory Infection (for Example, Pneumonia, Bronchitis), run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
This project aims to study the benefits of probiotics namely Bifidobacterium lactis M8 in treatment of upper and lower respiratory tract infections in young children, which are found common among children in Malaysia aged from 0-24 months. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Respiratory Infection (for Example, Pneumonia, Bronchitis)
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteMalaysia
- Study dates
- 29 Aug 2019to 3 Nov 2020
- 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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- young children aged 1-24 month, admitted to hospital for having respiratory diseases.
- Willing to commit throughout the experiment
Who cannot join
- Long term medication due to certain severe illness
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Trial locations and contacts
1 site in 1 country.
About this study
This project aims to study the benefits of probiotics namely Bifidobacterium lactis M8 in treatment of upper and lower respiratory tract infections in young children, which are found common among children in Malaysia aged from 0-24 months.
Read the detailed description
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. 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.
Among the various types of probiotics, 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 preventing diarrhea and/or respiratory-related illness prevalence in young children.
Bifidobacterium lactis M8 was isolated from breast milk samples collected from healthy woman in China. M8 was selected as it was the best among 857 other strains with excellent tolerance to gastric acid, intestinal fluid and bile salt of the digestive system. M8 is manufactured under a ISO9001 and ISO22000 certified manufacturing plant (JinHua YinHe Biological Technology Co. Ltd., China). M8 does not contain any porcine or bovine ingredients and has obtained the HALAL certification from ARA HALAL Development Services Center Inc. (ARA), which is recognized by JAKIM, Malaysia.
M8 is incorporated and sold in the market of China, Taiwan and Singapore in a variety of products, ranging from dairy (yoghurt and fermented milk). The product M8 contains good bacteria Bifidobacterium lactis M8 and primarily maltodextrin as carrier while placebo contains primarily maltodextrin. Sachets of products containing probiotic M8 and placebo appear as light yellow powder. Both M8 and placebo products are kept at storage temperature range below 30oC according to the condition recommended by the manufacturer.
A total number of 120 respiratory-related hospitalized children from age 0-24 months old will be recruited for this study.
- 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
Also called Bifidobacterium lactis M8
Oral administration of B. lactis M8 at 10 log CFU/day for 4-weeks
PlaceboDietary supplement
Oral administration of maltodextrin daily for 4-weeks
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Bifidobacterium lactis M8 at 10 log CFU/day for 4 weeks Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Intervention consists of daily administration of 1g of maltodextrin, administered daily for 4-weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospitalization in young children with respiratory tract infections upon administration of B. lactis M8
Differences in duration of hospitalization in young children with respiratory tract infections upon administration of B. lactis M8 at 10 log CFU/day compared to placebo
Measured: 4-weeks
Secondary outcomes (5)
Clinical symptoms in young children with respiratory tract infections upon administration of B. lactis M8 as assessed using the Monthly Health Questionnaire (as used in ClinicalTrials.gov (identifier number NCT02434042).
Differences in number of days and duration of symptoms of young children with respiratory tract infections upon administration of B. lactis M8 at 10 log CFU/day compared to placebo
Measured: 4-weeks
Clinical symptoms in young children with respiratory tract infections upon administration of B. lactis M8 as assessed using the Monthly Gastrointestinal Questionnaire as used in ClinicalTrials.gov (identifier number NCT02434042).
Differences in number of days and duration of symptoms of young children with gastrointestinal infections upon administration of B. lactis M8 at 10 log CFU/day compared to placebo
Measured: 4-weeks
Microbiota profiles of saliva and fecal samples in young children with respiratory tract infections upon administration of B. lactis M8 as assessed via pyrosequencing
Differences in microbiota abundance of saliva and fecal sample in young children with respiratory tract infections upon administration of B. lactis M8 at 10 log CFU/day compared to placebo
Measured: 4-weeks
Concentrations of proteins in saliva and fecal samples in young children with respiratory tract infections upon administration of B. lactis M8 as assessed via biochemical tests
Differences in concentrations of protein such as interleukins (IL-10, IL-4, IL-6, TNF-alpha, IFN-gamma) in saliva (ug/mL) and fecal (ug/mg) sample in young children with with respiratory tract infections upon administration of B. lactis M8 at 10 log CFU/day compared to placebo
Measured: 4-weeks
Gene expressions for inflammation and immunity from saliva and fecal samples in young children with respiratory tract infections upon administration of B. lactis M8 as assessed via real time PCR
Differences in gene expressions for inflammation (IL-10, IL-4, IL-6, TNF-alpha, IFN-gamma), immunity (T-cell and B-cell) in unit of fold change or delta-delta CT values, of saliva and fecal sample in young children with respiratory tract infections upon administration of B. lactis M8 at 10 log CFU/day compared to placebo
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start29 Aug 2019
- Primary completion3 Nov 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Scitop Bio-Tech Shareholding Co.Ltd.
- Responsible party
- Principal investigator, Min-Tze LIONG, Universiti Sains Malaysia
- Investigators
- Min Tze Liong, PhD, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122495
- Sponsor's protocol ID
- USM/JEPEM/19030177
- Status last verified
- Apr 2021
- First submitted
- 30 Sep 2019
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mageswary MU, Ang XY, Lee BK, Chung YF, Azhar SNA, Hamid IJA, Bakar HA, Roslan NS, Liu X, Kang X, Dai L, Sreenivasan S, Taib F, Zhang H, Liong MT. Probiotic Bifidobacterium lactis Probio-M8 treated and prevented acute RTI, reduced antibiotic use and hospital stay in hospitalized young children: a randomized, double-blind, placebo-controlled study. Eur J Nutr. 2022 Apr;61(3):1679-1691. doi: 10.1007/s00394-021-02689-8. Epub 2021 Nov 26.
PubMed 34825264
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Upper and Lower Respiratory Tract Infections in Young Children Using Probiotic
- ClinicalTrials.gov ID
- NCT04122495
- Acronym / sponsor ID
- USM/JEPEM/19030177
- Keywords
- probiotic, respiratory tract infections, Bifidobacterium, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Beijing Scitop Bio-Tech Shareholding Co.Ltd.
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 10 Oct 2019 (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 lactis M8 in treatment of upper and lower respiratory tract infections in young children, which are found common among children in Malaysia aged from 0-24 months.
Detailed description
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. 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.
Among the various types of probiotics, 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 preventing diarrhea and/or respiratory-related illness prevalence in young children.
Bifidobacterium lactis M8 was isolated from breast milk samples collected from healthy woman in China. M8 was selected as it was the best among 857 other strains with excellent tolerance to gastric acid, intestinal fluid and bile salt of the digestive system. M8 is manufactured under a ISO9001 and ISO22000 certified manufacturing plant (JinHua YinHe Biological Technology Co. Ltd., China). M8 does not contain any porcine or bovine ingredients and has obtained the HALAL certification from ARA HALAL Development Services Center Inc. (ARA), which is recognized by JAKIM, Malaysia.
M8 is incorporated and sold in the market of China, Taiwan and Singapore in a variety of products, ranging from dairy (yoghurt and fermented milk). The product M8 contains good bacteria Bifidobacterium lactis M8 and primarily maltodextrin as carrier while placebo contains primarily maltodextrin. Sachets of products containing probiotic M8 and placebo appear as light yellow powder. Both M8 and placebo products are kept at storage temperature range below 30oC according to the condition recommended by the manufacturer.
A total number of 120 respiratory-related hospitalized children from age 0-24 months old will be recruited for this study.
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 lactis M8 at 10 log CFU/day for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIntervention consists of daily administration of 1g of maltodextrin, administered daily for 4-weeks |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- young children aged 1-24 month, admitted to hospital for having respiratory diseases.
- Willing to commit throughout the experiment
Key exclusion criteria (2 listed)
- Long term medication due to certain severe illness
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
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 |
|---|---|---|
| ProbioticAlso: Bifidobacterium lactis M8Oral administration of B. lactis M8 at 10 log CFU/day for 4-weeks | Dietary supplement | Probiotic |
| PlaceboOral administration of maltodextrin daily for 4-weeks | Dietary supplement | Placebo |
Primary outcome
Duration of hospitalization in young children with respiratory tract infections upon administration of B. lactis M8
Time frame: 4-weeks
Differences in duration of hospitalization in young children with respiratory tract infections upon administration of B. lactis M8 at 10 log CFU/day compared to placebo
5 secondary outcomes
Clinical symptoms in young children with respiratory tract infections upon administration of B. lactis M8 as assessed using the Monthly Health Questionnaire (as used in ClinicalTrials.gov (identifier number NCT02434042).
Time frame: 4-weeks
Clinical symptoms in young children with respiratory tract infections upon administration of B. lactis M8 as assessed using the Monthly Gastrointestinal Questionnaire as used in ClinicalTrials.gov (identifier number NCT02434042).
Time frame: 4-weeks
Microbiota profiles of saliva and fecal samples in young children with respiratory tract infections upon administration of B. lactis M8 as assessed via pyrosequencing
Time frame: 4-weeks
Concentrations of proteins in saliva and fecal samples in young children with respiratory tract infections upon administration of B. lactis M8 as assessed via biochemical tests
Time frame: 4-weeks
Gene expressions for inflammation and immunity from saliva and fecal samples in young children with respiratory tract infections upon administration of B. lactis M8 as assessed via real time PCR
Time frame: 4-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 34825264Mageswary MU, Ang XY, Lee BK, Chung YF, Azhar SNA, Hamid IJA, Bakar HA, Roslan NS, Liu X, Kang X, Dai L, Sreenivasan S, Taib F, Zhang H, Liong MT. Probiotic Bifidobacterium lactis Probio-M8 treated and prevented acute RTI, reduced antibiotic use and hospital stay in hospitalized young children: a randomized, double-blind, placebo-controlled study. Eur J Nutr. 2022 Apr;61(3):1679-1691. doi: 10.1007/s00394-021-02689-8. Epub 2021 Nov 26.
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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.
Min Tze Liong, PhD principal investigator
Universiti Sains 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 Universiti Sains Malaysia 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 2 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: finished, as of the sponsor's last update on 29 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of hospitalization in young children with respiratory tract infections upon administration of B. lactis M8 (time frame: 4-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 NCT04122495, which also lists 1 linked publication.
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 29 Apr 2021.