Modulation of Gut Microbiota by Probiotic in Children

NCT06474234 | Recruiting Phase 2

• 1 other identifier: JEP-2023-972
• 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 healthy children, among pre-school children in Malaysia \<7 years old.

Conditions

Generally Healthy

Keywords

Bifidobacterium; probiotic; children

Outcome Measures

Primary Outcomes (1)

• Microbiota profiles of fecal samples in generally healthy children upon administration of probiotic as assessed via pyrosequencing

  Differences in microbiota abundance in fecal sample of generally healthy children upon administration o probiotic compared to placebo

  12-weeks

Secondary Outcomes (3)

• Clinical respiratory symptoms duration and frequency in generally healthy children 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 generally healthy children upon administration of probiotic as assessed using the Monthly Gastrointestinal Questionnaire as used in ClinicalTrials.gov (identifier number NCT02434042)

  12-weeks

• Immunity profiles in generally healthy children 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: 1 Month - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preschool children (\<7 years old)
• Born full-term (≥37 weeks delivered)
• In generally good health as determined by the investigator

You may not qualify if:

• Had taken probiotics or prebiotics within past 4-weeks
• Had taken milk powder or supplements containing probiotics within past 4-weeks
• History of using antibiotic within past 4-weeks
• Suffering from serious acute or chronic diseases (cardiovascular disease, gastrointestinal disease, endocrine disease, immune system disease, metabolic disease, etc.)
• Using other drugs that may interfere with the experimental results
• Participated in other experimental trials less than 8-weeks prior to this study

Sponsors & Collaborators

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

Study Sites (1)

UKM Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Adli Ali, MD

CONTACT

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

Min Tze Liong, PhD

CONTACT

604 653 2114; mintze.liong@usm.my

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: June 19, 2024
• First Posted: June 25, 2024
• Study Start: May 29, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)