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Effects of Bifidobacterium Longum BB536 on Incidence of Acute Diarrhea and/or Respiratory- Related Illnesses in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02434042
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : November 6, 2017
Morinaga Milk Industry Co., LTD
Information provided by (Responsible Party):
Min-Tze LIONG, Universiti Sains Malaysia

Brief Summary:
This project aims to study the benefits of probiotics namely Bifidobacterium longum BB536 in prevention of acute diarrhea and/or respiratory-related illnesses, which are found common among children in Malaysia aged from 2 to 6 years.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Dietary Supplement: BB536 Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Study on Oral Administration of Bifidobacterium Longum BB536 on Incidence of Acute Diarrhea and/or Respiratory- Related Illnesses Compared to Placebo
Actual Study Start Date : April 1, 2015
Actual Primary Completion Date : February 28, 2016
Actual Study Completion Date : February 28, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Dextrin

Arm Intervention/treatment
Active Comparator: BB536
Bifidobacterium longum BB536 (9 log CFU/day) and dextrin
Dietary Supplement: BB536
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 Name: Bifidobacterium longum BB536

Placebo Comparator: Placebo
100% dextrin
Other: Placebo
Intervention consists of daily administration of 1g of 100% dextrin, administer daily for five days a week and continue for 10 months.
Other Name: 100% dextrin

Primary Outcome Measures :
  1. Absentia between BB536 vs. Placebo children in daycare centers due to diarrhea and/or respiratory-related illnesses [ Time Frame: 10 monhts ]
  2. Severity of diarrhea between BB536 vs. Placebo children [ Time Frame: 10 months ]
  3. Severity of respiratory-related illnesses between BB536 vs. Placebo children [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. Fecal microbiota profiles of BB536 vs. Placebo children [ Time Frame: 10 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02434042

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School of Industrial Technology, Universiti Sains Malaysia
Pulau Pinang, Malaysia, 11900
Sponsors and Collaborators
Universiti Sains Malaysia
Morinaga Milk Industry Co., LTD
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Principal Investigator: Min Tze Liong, PhD Universiti Sains Malaysia
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Responsible Party: Min-Tze LIONG, Associate Professor Dr, Universiti Sains Malaysia Identifier: NCT02434042    
Other Study ID Numbers: 304/PTEKIND/650689
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Keywords provided by Min-Tze LIONG, Universiti Sains Malaysia:
upper respiratory
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive