NCT05734417

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

February 8, 2023

Last Update Submit

October 2, 2023

Conditions

Respiratory Tract Infections

Keywords

probioticrespiratory tract infectionsBifidobacteriumchildren

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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).

    4-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).

    4-weeks

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

    4-weeks

  • Concentrations of proteins in saliva samples in children with respiratory tract infections upon administration of probiotic as assessed via biochemical tests

    4-weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Intervention consists of daily administration of 2g/sachet of excipient administered daily for 4-weeks

Dietary Supplement: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

Oral administration of Bifidobacterium lactis subsp. infantis B8762 at 0.5x10 log colony forming unit (CFU)/day for 4-weeks

Also known as: Bifidobacterium lactis subsp. infantis B8762
Probiotic
PlaceboDIETARY_SUPPLEMENT

Intervention consists of daily administration of 2g/sachet of excipient administered daily for 4-weeks

Placebo

Eligibility Criteria

Age1 Month - 84 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • preschool children (\<7 years old), and having respiratory and/or gastrointestinal diseases symptoms.
  • Willing to commit throughout the experiment

You may not qualify if:

  • Long term medication due to certain severe illness (6 months or more)
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Paediatrics, Kulliyyah of Medicine, IIUM Medical Centre, International Islamic University Malaysia

Kuantan, Pahang, 25200, Malaysia

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Taufiq Hidayat Hasan, MBBS

    International Islamic University Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taufiq Hidayat Hasan, MBBS

CONTACT

0664214539dr_taufiq@iium.edu.my

Min Tze Liong, PhD

CONTACT

046532114mintze.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

February 8, 2023

First Posted

February 21, 2023

Study Start

May 1, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)