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Treatment of Upper and Lower Respiratory Tract Infections in Young Children Using Probiotic

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ClinicalTrials.gov Identifier: NCT04122495
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
Beijing Scitop Bio-Tech Shareholding Co.Ltd.
Information provided by (Responsible Party):
Min-Tze LIONG, University of Science Malaysia

Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Infection (for Example, Pneumonia, Bronchitis) Dietary Supplement: Probiotic Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Upper and Lower Respiratory Tract Infections in Young Children Using Probiotic
Actual Study Start Date : August 29, 2019
Estimated Primary Completion Date : August 28, 2020
Estimated Study Completion Date : August 28, 2020

Arm Intervention/treatment
Experimental: Probiotic
Bifidobacterium lactis M8 at 10 log CFU/day for 4 weeks
Dietary Supplement: Probiotic
Oral administration of B. lactis M8 at 10 log CFU/day for 4-weeks
Other Name: Bifidobacterium lactis M8

Placebo Comparator: Placebo
Intervention consists of daily administration of 1g of maltodextrin, administered daily for 4-weeks
Dietary Supplement: Placebo
Oral administration of maltodextrin daily for 4-weeks




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Clinical symptoms in young children with respiratory tract infections upon administration of B. lactis M8 as assessed using the Monthly Health Questionnaire [ Time Frame: 4-weeks ]
    Differences in clinical symptoms scores of young children with respiratory tract infections upon administration of B. lactis M8 at 10 log CFU/day compared to placebo

  2. Clinical symptoms in young children with respiratory tract infections upon administration of B. lactis M8 as assessed using the Monthly Gastrointestinal Questionnaire [ Time Frame: 4-weeks ]
    Differences in gastrointestinal symptoms scores of young children with respiratory tract infections upon administration of B. lactis M8 at 10 log CFU/day compared to placebo

  3. 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 ]
    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

  4. 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 ]
    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

  5. 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 ]
    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



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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • young children aged 1-24 month, admitted to hospital for having respiratory diseases.
  • Willing to commit throughout the experiment

Exclusion Criteria:

  • 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 ClinicalTrials.gov identifier (NCT number): NCT04122495


Contacts
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Contact: Min Tze Liong, PhD 6046532114 mintze.liong@usm.my
Contact: Fahisham Taib, MMEDSCI 6097676515 fahisham@usm.my

Locations
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Malaysia
Hospital USM Recruiting
Kubang Kerian, Kelantan, Malaysia, 16150
Contact: Fahisham Taib, MMEDSCI    6097676515    fahisham@usm.my   
Sponsors and Collaborators
University of Science Malaysia
Beijing Scitop Bio-Tech Shareholding Co.Ltd.
Investigators
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Principal Investigator: Min Tze Liong, PhD University of Science Malaysia

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Responsible Party: Min-Tze LIONG, Prof. (Clinical Professor), University of Science Malaysia
ClinicalTrials.gov Identifier: NCT04122495     History of Changes
Other Study ID Numbers: USM/JEPEM/19030177
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Min-Tze LIONG, University of Science Malaysia:
probiotic
respiratory tract infections
Bifidobacterium
children
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Pneumonia
Bronchitis
Lung Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive