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

Respiratory Infection (for Example, Pneumonia, Bronchitis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04122495
• Other study ID #: USM/JEPEM/19030177
• Status: Completed
• Phase: N/A
• Start date: August 29, 2019
• Est. completion date: November 3, 2020

Study information

• Verified date: April 2021
• Source: Universiti Sains Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 3, 2020
• Est. primary completion date: November 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Bronchitis
• Communicable Diseases
• Infection
• Pneumonia
• Respiratory Infection (for Example, Pneumonia, Bronchitis)
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Probiotic
Oral administration of B. lactis M8 at 10 log CFU/day for 4-weeks
• Placebo
Oral administration of maltodextrin daily for 4-weeks

Locations

Country	Name	City	State
Malaysia	Hospital USM	Kubang Kerian	Kelantan

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Sains Malaysia	Beijing Scitop Bio-Tech Shareholding Co.Ltd.

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of hospitalization in young children with respiratory tract infections upon administration of B. lactis M8	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	4-weeks
Secondary	Clinical symptoms in young children with respiratory tract infections upon administration of B. lactis M8 as assessed using the Monthly Health Questionnaire (as used in ClinicalTrials.gov (identifier number NCT02434042).	Differences in number of days and duration of symptoms of young children with respiratory tract infections upon administration of B. lactis M8 at 10 log CFU/day compared to placebo	4-weeks
Secondary	Clinical symptoms in young children with respiratory tract infections upon administration of B. lactis M8 as assessed using the Monthly Gastrointestinal Questionnaire as used in ClinicalTrials.gov (identifier number NCT02434042).	Differences in number of days and duration of symptoms of young children with gastrointestinal infections upon administration of B. lactis M8 at 10 log CFU/day compared to placebo	4-weeks
Secondary	Microbiota profiles of saliva and fecal samples in young children with respiratory tract infections upon administration of B. lactis M8 as assessed via pyrosequencing	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-weeks
Secondary	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	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	4-weeks
Secondary	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	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	4-weeks