- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02434042
Effects of Bifidobacterium Longum BB536 on Incidence of Acute Diarrhea and/or Respiratory- Related Illnesses in Children
Study on Oral Administration of Bifidobacterium Longum BB536 on Incidence of Acute Diarrhea and/or Respiratory- Related Illnesses Compared to Placebo
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Data from WHO revealed that 5.2 million of children under five of age die every year due to preventable disease such as diarrhea, malaria and pneumonia. 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.
Probiotics are preparations of bacteria and yeasts that are considered to confer a beneficial health effect when taken in an adequate amount. Bifidobacterium longum BB536, is a probiotic with over 100 scientific publications based on in vitro, in vivo, and clinical studies, with long consumption history supporting safety and health benefits.
BB536 is also commercially available in Malaysia and Japan in the form of food supplement and health supplements. Some of these include health supplements for children such as MAXBIOTICS, KidsBiotics and JANIPRO BB-G. All these three brands are sold in Malaysia and they all contain mixture of raw ingredient Bifidobacterium longum BB536 manufactured by Morinaga Milk Industry Co., Ltd. and other probiotic strains. In this study, the investigational product, Bifidobacterium longum BB536 and placebo is manufactured by Morinaga Milk Industry Co. Ltd., Japan.
Morinaga BB536 had been awarded FOSHU (Food for Specified Health Uses) status by Japan's Ministry of Health, Labour and Welfare. This status is granted to food products that have been shown in human clinical studies to demonstrate specific health benefits. Also, in year 2007, BB536 had obtained GRAS (Generally Recognised As Safe) certification in USA by FDA. BB536 has confirmed its safety for consumption as it is made in HACCP certified manufacturing plant (Pacific Resources, 2012). BB536 does not contain any porcine or bovine ingredients and has obtained the HALAL certification from the Japan Muslim Association (JMA), Japan. JMA is recognized by JAKIM, Malaysia.
Morinaga B. longum BB536 has been the subject of extensive clinical research and technical development with evidences from more than 100 scientific publications. There are no side effects been reported from the consumption of BB536 including premature infants, pregnant women, elderly people and patients who are taking immunosuppressive drugs. Based on in vitro, in vivo, and clinical studies, long consumption history (more than 30 years) support the safety and health benefits of the strain BB536 by improving intestinal environment, prevention of diarrhea, alleviation of constipation as well as supporting immune system. Based on previous study, ingestion of yogurt fortified with B. longum BB536 can help to reduce 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. There was also clinical trial done on infants in Hidaka General Hospital through the administration of lyophilized powder containing B. longum BB536 and B. breve M-16V each at 9 log cfu/sachet. Such findings suggest that B. longum BB536 is safe and could be used further to evaluate its effect in preventing diarrhea and/or respiratory-related illness prevalence in children from daycare centres.
A total number of five hundred and twenty (520) healthy children from age 2-6 years old will be recruited for this study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Pulau Pinang, Malaysia, 11900
- School of Industrial Technology, Universiti Sains Malaysia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male/ female subjects
- 2-6 years old
- BMI within a healthy range (between 5th to 84th percentile according to children BMI-for-age chart)
- Willing to commit throughout the experiment
Exclusion Criteria:
- Type-1 diabetes
- Long term medication due to certain severe illness
- HIV/AIDS
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: BB536
Bifidobacterium longum BB536 (9 log CFU/day) and dextrin
|
Intervention consists of daily administration of 1g probiotic Bifidobacterium longum BB536, administer daily for five days a week at a fixed dosage of 9 log CFU/day for BB536 and continue for 10 months.
Other Names:
|
Placebo Comparator: Placebo
100% dextrin
|
Intervention consists of daily administration of 1g of 100% dextrin, administer daily for five days a week and continue for 10 months.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absentia between BB536 vs. Placebo children in daycare centers due to diarrhea and/or respiratory-related illnesses
Time Frame: 10 monhts
|
10 monhts
|
Severity of diarrhea between BB536 vs. Placebo children
Time Frame: 10 months
|
10 months
|
Severity of respiratory-related illnesses between BB536 vs. Placebo children
Time Frame: 10 months
|
10 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fecal microbiota profiles of BB536 vs. Placebo children
Time Frame: 10 months
|
10 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Min Tze Liong, PhD, Universiti Sains Malaysia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 304/PTEKIND/650689
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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