Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-27 @ 3:58 PM
Study NCT ID:
NCT07297966
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Clinical Efficacy of Antrrix Probiotics in Improving Recurrent Respiratory Infections in Infants and Young Children
Sponsor:
Min-Tze LIONG
Organization:
Study Overview
Official Title:
Evaluation of the Clinical Efficacy of Antrrix Probiotics in Improving Recurrent Respiratory Infections in Infants and Young Children
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is an 8-weeks, randomized controlled trial involving children under 6 years of age who meet clinical diagnostic criteria for RRTI. Participants are randomized to receive either probiotic or placebo. The primary clinical outcomes assessed are duration and frequency of respiratory symptoms and quality of life. To investigate potential mechanisms, stool samples were collected pre- and post-intervention for 16S rRNA gene sequencing to analyze changes in gut microbiota composition and identify specific bacterial taxa associated with clinical improvements.
Detailed Description:
Recurrent respiratory tract infection (RRTI) is a common pediatric condition with an increasing yearly incidence, seriously impacting children's growth, development, and quality of life. Younger children are particularly vulnerable, with notably high incidence rates in those under five years of age. RRTI can hinder physical development, contribute to the emergence of antibiotic resistance, increase school absenteeism, and place significant economic stress on families and the healthcare system. The underlying causes and disease mechanisms of RRTI are multifactorial, involving immune immaturity, environmental exposures, and microbial imbalance. Growing evidence suggests that disruptions in the gut microbiota may influence respiratory health through the gut-lung axis. Probiotics, by supporting microbiota homeostasis and modulating immune responses, have demonstrated potential in reducing the frequency and severity of respiratory infections in children. Given these connections, further investigation into the targeted use of probiotics to improve clinical outcomes in RRTI is essential for advancing preventive and therapeutic strategies in pediatric care.
Some pathways are proposed to explain how probiotics may improve recurrent respiratory tract infections (RRTI). The gastrointestinal tract and respiratory tract are interconnected components of the mucosal immune system. Immune responses generated in the gut can influence distant mucosal sites, including the lungs. Probiotics can stimulate gut-associated lymphoid tissue, leading to enhanced production of antigen-specific immunoglobulins (IgG, IgA), cytokines, and short-chain fatty acids. These immune mediators circulate systemically and contribute to strengthened respiratory defenses. In addition, the respiratory tract possesses its own microbial ecosystem, and maintaining the stability of this respiratory microbiota is essential for safeguarding respiratory health.
Children affected by RRTI often exhibit decreased levels of beneficial bacteria such as Bifidobacteria and Lactobacilli in the intestines. Dysbiosis weakens both local and systemic immunity, particularly through reduced production of immunoglobulins such as IgA. Probiotic supplementation can help restore microbial balance and enhance the host's immune profile. Reported outcomes include fewer and milder respiratory infections, shorter symptom duration, and improved immune parameters such as increased immunoglobulin levels and a more favorable T-cell profile. Importantly, probiotics have demonstrated a strong safety profile in pediatric populations.
Based on current scientific understanding, this project will focus on children under 6 years of age who meet clinical diagnostic criteria for RRTI. Probiotics, containing strains Dipro-CRL1505 and M-16V strains, will be administered for 8 weeks to evaluate clinical benefits and safety outcomes. Additionally, 16S rRNA sequencing will assess gut microbiota composition before treatment, at 4 weeks, and at 8 weeks. Through these combined clinical and microbiological measures, the study aims to clarify the therapeutic potential and underlying mechanisms of this probiotic intervention in children with RRTI.
Some pathways are proposed to explain how probiotics may improve recurrent respiratory tract infections (RRTI). The gastrointestinal tract and respiratory tract are interconnected components of the mucosal immune system. Immune responses generated in the gut can influence distant mucosal sites, including the lungs. Probiotics can stimulate gut-associated lymphoid tissue, leading to enhanced production of antigen-specific immunoglobulins (IgG, IgA), cytokines, and short-chain fatty acids. These immune mediators circulate systemically and contribute to strengthened respiratory defenses. In addition, the respiratory tract possesses its own microbial ecosystem, and maintaining the stability of this respiratory microbiota is essential for safeguarding respiratory health.
Children affected by RRTI often exhibit decreased levels of beneficial bacteria such as Bifidobacteria and Lactobacilli in the intestines. Dysbiosis weakens both local and systemic immunity, particularly through reduced production of immunoglobulins such as IgA. Probiotic supplementation can help restore microbial balance and enhance the host's immune profile. Reported outcomes include fewer and milder respiratory infections, shorter symptom duration, and improved immune parameters such as increased immunoglobulin levels and a more favorable T-cell profile. Importantly, probiotics have demonstrated a strong safety profile in pediatric populations.
Based on current scientific understanding, this project will focus on children under 6 years of age who meet clinical diagnostic criteria for RRTI. Probiotics, containing strains Dipro-CRL1505 and M-16V strains, will be administered for 8 weeks to evaluate clinical benefits and safety outcomes. Additionally, 16S rRNA sequencing will assess gut microbiota composition before treatment, at 4 weeks, and at 8 weeks. Through these combined clinical and microbiological measures, the study aims to clarify the therapeutic potential and underlying mechanisms of this probiotic intervention in children with RRTI.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: