Bifidobacterium Animalis Subsp. Lactis XLTG11 for Reduced Allergy Risk in Infants
This phase 2 study aims to evaluate if Bifidobacterium Animalis Subsp. Lactis XLTG11 probiotic can prevent allergy symptoms in infants, as measured by a hospital-based clinical questionnaire.
Probiotic
+ Placebo
Hypersensitivity
+ Immune System Diseases
Prevention Study
Summary
Study start date: January 1, 2024
Actual date on which the first participant was enrolled.This study focuses on the effects of a specific probiotic, Bifidobacterium Animalis Subsp. Lactis XLTG11, on the growth, development, and immune function of infants. The research aims to understand how this probiotic might reduce the risk of allergies in healthy infants and young children under 3 years old. The study is important because early childhood is a critical time for the development of the gut microbiome and immune system. Imbalances during this period can lead to allergies, respiratory issues, and gastrointestinal disorders, which are common health problems in children worldwide. During the 180-day trial, participants receive either the probiotic or a placebo daily. The study measures the benefits of the probiotic across various health areas, including allergies, respiratory, and gastrointestinal symptoms. It also evaluates safety outcomes such as growth parameters and bowel habits. To understand how the probiotic works, the study uses advanced techniques like shotgun metagenomic sequencing to analyze changes in gut bacteria. It also measures certain immune markers to see how the probiotic might strengthen the body's natural defenses. The main goal is to determine if the probiotic can reduce allergy symptoms in children, as assessed through a hospital-based clinical questionnaire.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.366 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 36 Months
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Universiti Sains Malaysia
Pulau Pinang, Malaysia