ClinicalTrials.Veeva

Menu

Effects of Probiotic Against Respiratory & Gastrointestinal Illnesses in Children

M

Min-Tze LIONG

Status

Enrolling

Conditions

Respiratory Tract Infections

Treatments

Dietary Supplement: Probiotic
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05734417
IIUM-2022-193: UKM-2023-603

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

1 to 84 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

Loading...

Central trial contact

Taufiq Hidayat Hasan, MBBS; Min Tze Liong, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems