Effects of Probiotic Against Respiratory & Gastrointestinal Illnesses in Children

Respiratory Tract Infections Clinical Trial

Official title:

Effects of Probiotic Against Respiratory & Gastrointestinal Illnesses in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05734417
• Other study ID #: IIUM-2022-193: UKM-2023-603
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: October 2023
• Source: Universiti Sains Malaysia
• Contact: Taufiq Hidayat Hasan, MBBS
• Phone: 0664214539
• Email: dr_taufiq[@]iium.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project aims to study the benefits of probiotics namely Bifidobacterium lactis subsp. infantis B8762 in treatment of respiratory and gastrointestinal illnesses in children, which are found common among pre-school children in Malaysia aged below 7-years old.

Description:

Respiratory and gastrointestinal 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 and gastrointestinal illnesses. While the precise mechanisms of using probiotics are largely unknown, speculations include: probiotics compete against pathogens; increase the barrier function in respiratory epithelium; immuno-stimulatory effects by enhancing cellular immunity with increased activity of natural killer cells and macrophages in airways and gut. Hence, probiotics may offer safe means of reducing the risk of respiratory and gastrointestinal illnesses, antibiotic use, and the risk of recurrent infections, thereby represent a simple, safe, effective, available and affordable method for preventing respiratory and gastrointestinal 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.

Probiotic (Bifidobacterium lactis subsp. infantis B8762) adheres to probiotic properties such as excellent tolerance to gastric acid, intestinal fluid and bile salt of the digestive system. Both probiotic and placebo products are manufactured under an ISO9001, ISO22000 and HACCP conditions. All products do not contain any animal-origin ingredients. The probiotic product contains probiotic and carrier while placebo contains only carrier. Sachets of products containing probiotic and placebo appear as light yellow powder. Both probiotic and placebo products are kept at storage temperature range below 30oC according to the condition recommended by the manufacturer.

A total number of 120 pre-school children with respiratory diseases aged below 7-years old will be recruited for this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 84 Months

Eligibility

Inclusion Criteria:

• preschool children (<7 years old), and having respiratory and/or gastrointestinal diseases symptoms.

• Willing to commit throughout the experiment

Exclusion Criteria:

• Long term medication due to certain severe illness (6 months or more)

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Related Conditions & MeSH terms

• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Probiotic
Oral administration of Bifidobacterium lactis subsp. infantis B8762 at 0.5x10 log colony forming unit (CFU)/day for 4-weeks
• Placebo
Intervention consists of daily administration of 2g/sachet of excipient administered daily for 4-weeks

Locations

Country	Name	City	State
Malaysia	Department of Paediatrics, Kulliyyah of Medicine, IIUM Medical Centre, International Islamic University Malaysia	Kuantan	Pahang

Sponsors (3)

Lead Sponsor	Collaborator
Min-Tze LIONG	Beijing Scitop Bio-Tech Co., Ltd., International Islamic University Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of respiratory illnesses in children with respiratory tract infections upon administration of probiotic for 4-weeks	Changes in duration of respiratory illnesses in children compared between probiotic and placebo after 4-weeks	4-weeks
Secondary	Clinical respiratory symptoms frequency in children with respiratory tract infections upon administration of probiotic as assessed using the Monthly Health Questionnaire (as used in ClinicalTrials.gov (identifier number NCT02434042).	Changes in frequency of respiratory illnesses symptoms from children on probiotic or placebo after 4-weeks, via the use of questionnaire.	4-weeks
Secondary	Clinical gastrointestinal symptoms in children with respiratory tract infections upon administration of probiotic as assessed using the Monthly Gastrointestinal Questionnaire as used in ClinicalTrials.gov (identifier number NCT02434042).	Differences in duration and frequency of gastrointestinal symptoms of children upon administration of probiotic compared to placebo	4-weeks
Secondary	Microbiota profiles of saliva and fecal samples in children with respiratory tract infections upon administration of probiotic as assessed via pyrosequencing	Differences in microbiota abundance of saliva and fecal sample in children with respiratory tract infections upon administration o probiotic compared to placebo	4-weeks
Secondary	Concentrations of proteins in saliva samples in children with respiratory tract infections upon administration of probiotic as assessed via biochemical tests	Differences in concentrations of proteins such as interleukins (IL-10, IL-4, IL-6, Tumour Necrosis Factor-alpha, Interferon gamma) in saliva (ug/mL) samples in children with with respiratory tract infections upon administration of probiotic compared to placebo	4-weeks