Respiratory Tract InfectionsNCT05734417
Effects of Probiotic Against Respiratory & Gastrointestinal Illnesses in Children
A study testing Probiotic in people with Respiratory Tract Infections, run by Min-Tze LIONG at 1 site in Malaysia.
Trial summary
This project aims to study the benefits of probiotics namely Bifidobacterium lactis subsp. infantis B8762 in treatment of respiratory and gastrointestinal illnesses in children, which are found common among pre-school children in Malaysia aged below 7-years old. Read more about this study
- Who is it for?
- Ages 1 month to 84 months
- Conditions the study is for
- Respiratory Tract Infections
- 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
- 1 May 2023to 1 Mar 2025
- 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 84 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preschool children (<7 years old), and having respiratory and/or gastrointestinal diseases symptoms.
- Willing to commit throughout the experiment
Who cannot join
- Long term medication due to certain severe illness (6 months or more)
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Department of Paediatrics, Kulliyyah of Medicine, IIUM Medical Centre, International Islamic University Malaysia
Kuantan, Pahang, 25200
Taufiq Hidayat Hasan, MBBS, 0364214539, dr_taufiq@iium.edu.my
Muhd Alwi Muhd Helmi, MBBS, 0364214542, muhdalwi@iium.edu.my
About this study
This project aims to study the benefits of probiotics namely Bifidobacterium lactis subsp. infantis B8762 in treatment of respiratory and gastrointestinal illnesses in children, which are found common among pre-school children in Malaysia aged below 7-years old.
Read the detailed description
Respiratory and gastrointestinal 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 and gastrointestinal illnesses. While the precise mechanisms of using probiotics are largely unknown, speculations include: probiotics compete against pathogens; increase the barrier function in respiratory epithelium; immuno-stimulatory effects by enhancing cellular immunity with increased activity of natural killer cells and macrophages in airways and gut. Hence, probiotics may offer safe means of reducing the risk of respiratory and gastrointestinal illnesses, antibiotic use, and the risk of recurrent infections, thereby represent a simple, safe, effective, available and affordable method for preventing respiratory and gastrointestinal 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.
Probiotic (Bifidobacterium lactis subsp. infantis B8762) 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 an ISO9001, ISO22000 and 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.
A total number of 120 pre-school children with respiratory diseases aged below 7-years old will be recruited for this study.
- Conditions
- Respiratory Tract Infections
- Being tested
- Probiotic, Placebo
- Keywords
- probiotic, respiratory tract infections, Bifidobacterium, children
- Medical subject headings
- Respiratory Tract Infections
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 subsp. infantis B8762
Oral administration of Bifidobacterium lactis subsp. infantis B8762 at 0.5x10 log colony forming unit (CFU)/day for 4-weeks
PlaceboDietary supplement
Intervention consists of daily administration of 2g/sachet of excipient administered daily for 4-weeks
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Intervention consists of daily administration of excipient plus Bifidobacterium lactis subsp. infantis B8762 at 0.5x10 log colony forming unit (CFU)/day administered daily for 4-weeks Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Intervention consists of daily administration of 2g/sachet of excipient 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 respiratory illnesses in children with respiratory tract infections upon administration of probiotic for 4-weeks
Changes in duration of respiratory illnesses in children compared between probiotic and placebo after 4-weeks
Measured: 4-weeks
Secondary outcomes (4)
Clinical respiratory symptoms 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 frequency of respiratory illnesses symptoms from children on probiotic or placebo after 4-weeks, via the use of questionnaire.
Measured: 4-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: 4-weeks
Microbiota profiles of saliva and fecal samples in children with respiratory tract infections upon administration of probiotic as assessed via pyrosequencing
Differences in microbiota abundance of saliva and fecal sample in children with respiratory tract infections upon administration o probiotic compared to placebo
Measured: 4-weeks
Concentrations of proteins in saliva samples in children with respiratory tract infections upon administration of probiotic as assessed via biochemical tests
Differences in concentrations of proteins such as interleukins (IL-10, IL-4, IL-6, Tumour Necrosis Factor-alpha, Interferon gamma) in saliva (ug/mL) samples in children with with respiratory tract infections upon administration of probiotic 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 posted21 Feb 2023
- Study start1 May 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies 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
- International Islamic University Malaysia, Beijing Scitop Bio-Tech Co., Ltd.
- Responsible party
- Sponsor-investigator, Min-Tze LIONG, Universiti Sains Malaysia
- Investigators
- Taufiq Hidayat Hasan, MBBS, Principal investigator, International Islamic University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734417
- Sponsor's protocol ID
- IIUM-2022-193: UKM-2023-603
- Status last verified
- Oct 2023
- First submitted
- 8 Feb 2023
- Last updated
- 4 Oct 2023
- 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 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotic Against Respiratory & Gastrointestinal Illnesses in Children
- ClinicalTrials.gov ID
- NCT05734417
- Acronym / sponsor ID
- IIUM-2022-193: UKM-2023-603
- Conditions
- Respiratory Tract Infections
- 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
- International Islamic University Malaysia, Beijing Scitop Bio-Tech Co., Ltd.
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 21 Feb 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 lactis subsp. infantis B8762 in treatment of respiratory and gastrointestinal illnesses in children, which are found common among pre-school children in Malaysia aged below 7-years old.
Detailed description
Respiratory and gastrointestinal 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 and gastrointestinal illnesses. While the precise mechanisms of using probiotics are largely unknown, speculations include: probiotics compete against pathogens; increase the barrier function in respiratory epithelium; immuno-stimulatory effects by enhancing cellular immunity with increased activity of natural killer cells and macrophages in airways and gut. Hence, probiotics may offer safe means of reducing the risk of respiratory and gastrointestinal illnesses, antibiotic use, and the risk of recurrent infections, thereby represent a simple, safe, effective, available and affordable method for preventing respiratory and gastrointestinal 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.
Probiotic (Bifidobacterium lactis subsp. infantis B8762) 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 an ISO9001, ISO22000 and 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.
A total number of 120 pre-school children with respiratory diseases aged below 7-years 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: ProbioticIntervention consists of daily administration of excipient plus Bifidobacterium lactis subsp. infantis B8762 at 0.5x10 log colony forming unit (CFU)/day administered daily for 4-weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIntervention consists of daily administration of 2g/sachet of excipient administered daily for 4-weeks |
Who may qualify
- Ages
- 1 month to 84 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- preschool children (<7 years old), and having respiratory and/or gastrointestinal diseases symptoms.
- Willing to commit throughout the experiment
Key exclusion criteria (2 listed)
- Long term medication due to certain severe illness (6 months or more)
- 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 subsp. infantis B8762Oral administration of Bifidobacterium lactis subsp. infantis B8762 at 0.5x10 log colony forming unit (CFU)/day for 4-weeks | Dietary supplement | Probiotic |
| PlaceboIntervention consists of daily administration of 2g/sachet of excipient administered daily for 4-weeks | Dietary supplement | Placebo |
Primary outcome
Duration of respiratory illnesses in children with respiratory tract infections upon administration of probiotic for 4-weeks
Time frame: 4-weeks
Changes in duration of respiratory illnesses in children compared between probiotic and placebo after 4-weeks
4 secondary outcomes
Clinical respiratory symptoms 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: 4-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: 4-weeks
Microbiota profiles of saliva and fecal samples in children with respiratory tract infections upon administration of probiotic as assessed via pyrosequencing
Time frame: 4-weeks
Concentrations of proteins in saliva samples in children with respiratory tract infections upon administration of probiotic as assessed via biochemical tests
Time frame: 4-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Respiratory Tract Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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.
Taufiq Hidayat Hasan, MBBS principal investigator
International Islamic University 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 Tract Infections, 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 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: status not confirmed, as of the sponsor's last update on 4 Oct 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 Taufiq Hidayat Hasan, MBBS (0664214539, dr_taufiq@iium.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of respiratory illnesses in children with respiratory tract infections upon administration of probiotic for 4-weeks (time frame: 4-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 4 Oct 2023.