Modulation of Gut Microbiota by Probiotic in Children With Respiratory Symptoms

NCT05794815 | Recruiting

• 1 other identifier: UKMPPI/111/6/JEP-2023-074
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to study the benefits of probiotics namely Bifidobacterium infantis YLGB-1496 in modulating gut microbiota of children with respiratory symptoms, among pre-school children in Malaysia aged \>12 months old, \<7 years old.

Conditions

Respiratory Infection (for Example, Pneumonia, Bronchitis)

Keywords

probiotic; respiratory tract infections; Bifidobacterium; children

Outcome Measures

Primary Outcomes (1)

• Microbiota profiles of fecal samples in children with respiratory tract infections upon administration of probiotic as assessed via pyrosequencing

  Differences in microbiota abundance in fecal sample of children with respiratory tract infections upon administration o probiotic compared to placebo

  12-weeks

Secondary Outcomes (3)

• Clinical respiratory symptoms duration and 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)

  12-weeks

• 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)

  12-weeks

• Immunity profiles in children with respiratory tract infections upon administration of probiotic via the use of oral swabs

  12-weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Bifidobacterium infantis YLGB-1496 at 1x10 log CFU/day for 12 weeks

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Intervention consists of daily administration of 2g of maltodextrin, administered daily for 12-weeks)

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Bifidobacterium infantis YLGB-1496 at 1x10 log CFU/day for 12 weeks

Probiotic

Placebo DIETARY_SUPPLEMENT

Intervention consists of daily administration of 2g of maltodextrin, administered daily for 12-weeks)

Placebo

Eligibility Criteria

• Age: 12 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preschool children (\>12 months old, \<7 years old).
• Having respiratory symptoms (having at least two of the following signs and symptoms: fever (even if only reported not measured), nasal obstruction, chills, sore throat, headache, cough, runny nose, olfactory disturbances, or taste disturbances; Pucarelli-Lebreiro et al., 2022).
• Healthy with current weight of P20-P80 percentile chart of children
• Infant formula powder does not contain probiotics; prebiotics FOS is not allowed, GOS \<2g/ 100g is allowed
• Willing to commit throughout the experiment

You may not qualify if:

• Long term medication \>6 months for any diseases
• Deformity
• Mothers with metabolic and/or chronic diseases
• Current or previous diseases, conditions or interventions that may interfere with the study (such as tolerance and/or growth and development), such as gastrointestinal malformations, chronic diarrhea, malabsorption syndromes, malnutrition, congenital immunodeficiency or surgery
• Oral antibiotics within 2 weeks before the intervention
• Nutritional supplements containing probiotics and prebiotics (except infant formula) within 2 weeks before the intervention
• Foods for special medical purposes or non-standard formula powders for lactose intolerance and galactosemia
• Probiotic allergies or possible food allergies (milk, etc.)
• Participated in other clinical studies 4 weeks before the intervention
• Unwilling to participate for any particular reason

Sponsors & Collaborators

• Min-Tze LIONG: lead
• National University of Malaysia: collaborator

Study Sites (1)

UKM Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

Related Publications (2)

• Uma Mageswary M, Li P, Richmond RV, Azianey Y, Abd Hamid IJ, Taib F, Liong MT, Ali A, Tan JS, Zhang Y. Clinical benefits of Bifidobacterium infantis YLGB-1496 in modulating gut microbiota and immunity in young children. Front Nutr. 2026 Jan 5;12:1713135. doi: 10.3389/fnut.2025.1713135. eCollection 2025.

  PMID: 41561177 DERIVED

• Li P, Mageswary U, Ali A, Taib F, Koo TH, Yusof A, Jiang H, Lan H, Hung W, Liong MT, Zhang Y. Clinical effects of Bifidobacterium Longum Subsp. Infantis YLGB-1496 on children with respiratory symptoms. Front Nutr. 2025 Feb 19;12:1537610. doi: 10.3389/fnut.2025.1537610. eCollection 2025.

  PMID: 40046755 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Pneumonia; Bronchitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Adli Ali, MD

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adli Ali, MD

CONTACT

603 8921 5555; adli.ali@ppukm.ukm.edu.my

Min Tze Liong, PhD

CONTACT

6046532114; mintze.liong@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)