Healthy VolunteersNCT02541539
Effects of Lactobacillus Casei on Respiratory and Gastrointestinal Diseases in Adults
A study testing Lactobacillus casei Zhang in people with Healthy Volunteers, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang (LCZ) in prevention of upper respiratory and gastrointestinal illnesses, which are found common among adults in Malaysia aged from 18 to 81 years. Read more about this study
- Who is it for?
- Ages 18 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Lactobacillus casei Zhang
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2015to 30 Sep 2016
- 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 18 to 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male/ female subjects
- 18-81 years old
- Body mass index (BMI) within a healthy range
- Willing to commit throughout the experiment
Who cannot join
- Type-1 diabetes
- Long term medication due to certain severe illness
- Human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS)
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Vegetarian
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
School of Industrial Technology, Universiti Sains Malaysia
Pulau Pinang, Pulau Pinang, 11800
About this study
Official title: Effects of Lactobacillus Casei in the Prevention of Upper Respiratory and Diarrheal Diseases Among Adults
This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang (LCZ) in prevention of upper respiratory and gastrointestinal illnesses, which are found common among adults in Malaysia aged from 18 to 81 years.
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 tract infections (RTI) can be described as infections on sinuses, throat, airways and lungs. Generally, RTI can be categorized into upper respiratory tract infections (URTI) and lower respiratory tract infections (LRTI). Some of the common URTI are like common cold, sinusitis, pharyngitis, epiglottitis and laryngotracheitis (croup) while examples of LRTI are bronchitis, bronchiolitis and pneumonia. URTI will be the main focus of this research. Despite continuous medical advancement, URTI remains a burden to the vast global communities.In Malaysia, URTI take out a proportion of 16.5% and 21.2% of the diseases diagnosed in public and private health clinics respectively.
Diarrhea is one of the most common symptoms for gastrointestinal diseases. Diarrhea is commonly defined as three or more loose or watery stools in the last 24 hours. Probiotics such as Lactobacillus GG, Bifidobacterium lactis (alone or in combination with Streptococcus thermophiles), and Lactobacillus reuteri, Lactobacillus casei and Lactobacillus acidophilus have been reported to reduce diarrhea-related symptoms in a strain-dependent and dose-dependent manner. 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.
Lactobacillus casei Zhang (LCZ) has been identified as a unique probiotic strain that shows favorable probiotic characteristics like high acid and bile tolerance, ability to colonize gastrointestinal tract, in addition to antibacterial, antioxidative and immunomodulatory properties. LCZ was first isolated from koumiss collected in Xilin Guole, Inner Mongolia, China by a group of researchers from Inner Mongolia Agricultural University. Koumiss is a type of fermented horse milk drink which is commonly found in Inner Mongolia, China and has been reported to treat digestive diseases and chronic diseases.
LCZ is already commercially available and currently marketed in China since 2010, in the form of beverages, tablets, powders and capsules. Among the well known products present in the market are Bio-Plus, a type of plant based fermented soymilk beverages, Sci-Plus, and a multiple probiotic tablet. Research and development involving LCZ have won many awards. Among them are 2009 National Science and Technology Progress Award of China (second prize), 2009 Inner Mongolia Natural Science Award (first prize) and the sixth DBN Technology Achievement Award. In addition, up to September 2014, 11 patents were filed and approved while 8 more patents were in the review stage. Besides that, 82 research papers related to LCZ were also published.
Most research on LCZ have been related to improving human's health such as reduce susceptibility to type II diabetes and enhance human's immune system, and also related to food industry usage such as in cheese making industry. More importantly, many of probiotics have been reported to exert health benefits via maintain a healthy gut profile. In a recent clinical study, LCZ was found to significantly altered the composition of intestinal microbiota and the gut microbiota diversity, with a positive correlation with beneficial microorganisms such as Lactobacillus, Bifidobacterium and an unidentified genus from Bacteroidaceae, and a negative correlation with detrimental pathogens such as Clostridium, Serratia, Enterococcus, Shigella and Shewanella, with just a consumption of 28 days.
LCZ has confirmed its safety for consumption, and for this intervention, it will be produced in a HACCP and ISO 22000 certified manufacturing plant (GeneFerm Biotechnology Co., Ltd., Taiwan). LCZ does not contain any porcine or bovine ingredients and has obtained the Halal certification from Taiwan Halal Integrity Development Association (THIDA), Taiwan, which is recognized by Jabatan Kemajuan Islam Malaysia (JAKIM), an organization that oversees the implementation of Halal requirement in Malaysia.
A total number of 150 healthy adults from age 18 -81 years old will be recruited for this study.
- Conditions
- Healthy Volunteers
- Being tested
- Lactobacillus casei Zhang, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus casei ZhangDietary supplement
Also called LCZ
This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang in prevention of upper respiratory and gastrointestinal illnesses, among adults in Malaysia aged from 18-81 years.
PlaceboDietary supplement
This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang in prevention of upper respiratory and gastrointestinal illnesses, among adults in Malaysia aged from 18-81 years.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus casei Zhang | Active comparator | Intervention consists of daily administration of 2g probiotic Lactobacillus casei Zhang, administered daily at a fixed dosage of 9 log CFU/sachet/day and continue for 12 months. Receives: Dietary Supplement: Lactobacillus casei Zhang |
| Placebo | Placebo comparator | Intervention consists of daily administration of 2g placebo (no probiotic bacteria), administered daily and continue for 12 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum immunoglobulin-A (IgA) level
IgA as an indicator for immunology, in assessing severity of upper respiratory illnesses between number of adult participants taking LCZ vs. placebo
Measured: 12 months
Bristol stool chart scale
Bristol stool scale (from a scale of 1-7; scale of 1 representing hard lump, and 7 representing liquid with no solid pieces) as an indicator for assessing severity of gastrointestinal-related diarrheal illnesses between number of adult participants taking LCZ vs. placebo
Measured: 12 months
Secondary outcomes (1)
Fecal microbiota profiling
Deoxyribonucleic acid (DNA) sequencing of fecal samples to compare DNA sequences of the different microbiota between adult participants taking LCZ vs. placebo
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study start1 Oct 2015
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
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 Healthy VolunteersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Inner Mongolia University of Science and Technology
- Responsible party
- Principal investigator, Min-Tze LIONG, Universiti Sains Malaysia
- Investigators
- Min tze Liong, PhD, Principal investigator, USM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541539
- Sponsor's protocol ID
- 15020059
- Status last verified
- Nov 2017
- First submitted
- 24 Aug 2015
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang J, Wang L, Guo Z, Sun Z, Gesudu Q, Kwok L, Menghebilige, Zhang H. 454 pyrosequencing reveals changes in the faecal microbiota of adults consuming Lactobacillus casei Zhang. FEMS Microbiol Ecol. 2014 Jun;88(3):612-22. doi: 10.1111/1574-6941.12328.
PubMed 24702028
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lactobacillus Casei in the Prevention of Upper Respiratory and Diarrheal Diseases Among Adults
- ClinicalTrials.gov ID
- NCT02541539
- Acronym / sponsor ID
- 15020059
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Inner Mongolia University of Science and Technology
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 4 Sep 2015 (estimated)
- 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 Lactobacillus casei Zhang (LCZ) in prevention of upper respiratory and gastrointestinal illnesses, which are found common among adults in Malaysia aged from 18 to 81 years.
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 tract infections (RTI) can be described as infections on sinuses, throat, airways and lungs. Generally, RTI can be categorized into upper respiratory tract infections (URTI) and lower respiratory tract infections (LRTI). Some of the common URTI are like common cold, sinusitis, pharyngitis, epiglottitis and laryngotracheitis (croup) while examples of LRTI are bronchitis, bronchiolitis and pneumonia. URTI will be the main focus of this research. Despite continuous medical advancement, URTI remains a burden to the vast global communities.In Malaysia, URTI take out a proportion of 16.5% and 21.2% of the diseases diagnosed in public and private health clinics respectively.
Diarrhea is one of the most common symptoms for gastrointestinal diseases. Diarrhea is commonly defined as three or more loose or watery stools in the last 24 hours. Probiotics such as Lactobacillus GG, Bifidobacterium lactis (alone or in combination with Streptococcus thermophiles), and Lactobacillus reuteri, Lactobacillus casei and Lactobacillus acidophilus have been reported to reduce diarrhea-related symptoms in a strain-dependent and dose-dependent manner. 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.
Lactobacillus casei Zhang (LCZ) has been identified as a unique probiotic strain that shows favorable probiotic characteristics like high acid and bile tolerance, ability to colonize gastrointestinal tract, in addition to antibacterial, antioxidative and immunomodulatory properties. LCZ was first isolated from koumiss collected in Xilin Guole, Inner Mongolia, China by a group of researchers from Inner Mongolia Agricultural University. Koumiss is a type of fermented horse milk drink which is commonly found in Inner Mongolia, China and has been reported to treat digestive diseases and chronic diseases.
LCZ is already commercially available and currently marketed in China since 2010, in the form of beverages, tablets, powders and capsules. Among the well known products present in the market are Bio-Plus, a type of plant based fermented soymilk beverages, Sci-Plus, and a multiple probiotic tablet. Research and development involving LCZ have won many awards. Among them are 2009 National Science and Technology Progress Award of China (second prize), 2009 Inner Mongolia Natural Science Award (first prize) and the sixth DBN Technology Achievement Award. In addition, up to September 2014, 11 patents were filed and approved while 8 more patents were in the review stage. Besides that, 82 research papers related to LCZ were also published.
Most research on LCZ have been related to improving human's health such as reduce susceptibility to type II diabetes and enhance human's immune system, and also related to food industry usage such as in cheese making industry. More importantly, many of probiotics have been reported to exert health benefits via maintain a healthy gut profile. In a recent clinical study, LCZ was found to significantly altered the composition of intestinal microbiota and the gut microbiota diversity, with a positive correlation with beneficial microorganisms such as Lactobacillus, Bifidobacterium and an unidentified genus from Bacteroidaceae, and a negative correlation with detrimental pathogens such as Clostridium, Serratia, Enterococcus, Shigella and Shewanella, with just a consumption of 28 days.
LCZ has confirmed its safety for consumption, and for this intervention, it will be produced in a HACCP and ISO 22000 certified manufacturing plant (GeneFerm Biotechnology Co., Ltd., Taiwan). LCZ does not contain any porcine or bovine ingredients and has obtained the Halal certification from Taiwan Halal Integrity Development Association (THIDA), Taiwan, which is recognized by Jabatan Kemajuan Islam Malaysia (JAKIM), an organization that oversees the implementation of Halal requirement in Malaysia.
A total number of 150 healthy adults from age 18 -81 years old will be recruited for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus casei Zhang | Active comparator | Dietary Supplement: Lactobacillus casei ZhangIntervention consists of daily administration of 2g probiotic Lactobacillus casei Zhang, administered daily at a fixed dosage of 9 log CFU/sachet/day and continue for 12 months. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIntervention consists of daily administration of 2g placebo (no probiotic bacteria), administered daily and continue for 12 months. |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male/ female subjects
- 18-81 years old
- Body mass index (BMI) within a healthy range
- Willing to commit throughout the experiment
Key exclusion criteria (5 listed)
- Type-1 diabetes
- Long term medication due to certain severe illness
- Human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS)
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Vegetarian
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 |
|---|---|---|
| Lactobacillus casei ZhangAlso: LCZThis project aims to study the benefits of probiotics namely Lactobacillus casei Zhang in prevention of upper respiratory and gastrointestinal illnesses, among adults in Malaysia aged from 18-81 years. | Dietary supplement | Lactobacillus casei Zhang |
| PlaceboThis project aims to study the benefits of probiotics namely Lactobacillus casei Zhang in prevention of upper respiratory and gastrointestinal illnesses, among adults in Malaysia aged from 18-81 years. | Dietary supplement | Placebo |
Primary outcome
Serum immunoglobulin-A (IgA) level
Time frame: 12 months
IgA as an indicator for immunology, in assessing severity of upper respiratory illnesses between number of adult participants taking LCZ vs. placebo
Bristol stool chart scale
Time frame: 12 months
Bristol stool scale (from a scale of 1-7; scale of 1 representing hard lump, and 7 representing liquid with no solid pieces) as an indicator for assessing severity of gastrointestinal-related diarrheal illnesses between number of adult participants taking LCZ vs. placebo
1 secondary outcome
Fecal microbiota profiling
Time frame: 12 months
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 6 Nov 2017.
- Results publication: PubMed 24702028Zhang J, Wang L, Guo Z, Sun Z, Gesudu Q, Kwok L, Menghebilige, Zhang H. 454 pyrosequencing reveals changes in the faecal microbiota of adults consuming Lactobacillus casei Zhang. FEMS Microbiol Ecol. 2014 Jun;88(3):612-22. doi: 10.1111/1574-6941.12328.
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Screening Protocol
Pain
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
USM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus casei Zhang in people with Healthy Volunteers, 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 4 inclusion and 5 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 6 Nov 2017. 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?
Serum immunoglobulin-A (IgA) level (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT02541539, 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 6 Nov 2017.