Evaluation of the Clinical Efficacy of Antrrix Probiotics in Improving Recurrent Respiratory Infections in Infants and Young Children

NCT07297966 | Recruiting Phase 2

• 1 other identifier: (2024)-0001
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

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 metagenomics gene sequencing to analyze changes in gut microbiota composition and identify specific bacterial taxa associated with clinical improvements.

Conditions

Recurrent Respiratory Tract Infections

Keywords

RRTI; probiotic; RCT; children

Outcome Measures

Primary Outcomes (1)

• Respiratory symptoms in children upon administration of probiotic or placebo as assessed via clinical questionnaire

  Differences in severity of respiratory symptoms in children upon administration of probiotic or placebo, assessed using a hospital-based clinical questionnaire scored on a 5-point ordinal scale (0 = no symptoms to 4 = severe symptoms), with lower scores indicating better respiratory status.

  day 1, day 7, day 14, week 4, week 8

Secondary Outcomes (3)

• Quality of life in children upon administration of probiotic or placebo via clinical questionnaire

  day 1, day 7, day 14, week 4, week 8

• Microbiota profiles of fecal samples in young children upon administration of probiotic, lactulose or their combinations as assessed via metagenomics sequencing

  day 1, day 7, day 14, week 4, week 8

• Immune biomarker profiles of fecal samples in young children upon administration of probiotic, lactulose or their combinations as assessed via Enzyme-Linked Immunosorbent Assay (ELISA)

  day 1, day 7, day 14, week 4, week 8

Study Arms (2)

Probiotic

EXPERIMENTAL

Daily 2 × 10 9 CFU per 6 drops containing Lactobacillus rhamnosus CRL1505+Bifidobacterium brevis M-16V strain in MCT oil

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Daily 6 drops of MCT oil without probiotic

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Daily 6 drops MCT oil without probiotics

Placebo

Probiotic DIETARY_SUPPLEMENT

Daily 2 × 10 9 CFU per 6 drops containing Lactobacillus rhamnosus CRL1505+Bifidobacterium brevis M-16V strain in MCT oil

Probiotic

Eligibility Criteria

• Age: 1 Day - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age \< 6 years, gender not limited;
• Meets the clinical diagnostic criteria for recurrent respiratory tract infections (Clinical Diagnosis and Treatment Pathway for Recurrent Respiratory Tract Infections in Children (2022 Edition) 10 );
• Parents or other legal guardians of the child fully understand the trial and voluntarily sign informed consent forms before the start of any research procedure;
• Willing to discontinue the use of other probiotics during the trial;
• Agree to the collection of fecal biological samples during this trial.

You may not qualify if:

• Those deemed by the investigator to have poor compliance or be unsuitable for participation;
• Allergic to the investigational product and its components;
• Allergic to respiratory tract infection drugs and their components;
• Respiratory infections caused by underlying diseases such as primary immunodeficiency diseases, acquired immunodeficiency syndrome (ADRS), congenital airway malformations, congenital heart disease, gastroesophageal reflux disease (GERD), and pulmonary dysplasia;
• Patients with severe malnutrition, rickets, and severe primary diseases of the heart, brain, liver, kidney, and hematopoietic systems;
• Use probiotic preparations, antibiotics, immunostimulants, or immunosuppressants 4 weeks before participating in the experiment.

Sponsors & Collaborators

• Xinyi City People's Hospital: collaborator
• Min-Tze LIONG: lead

Study Sites (2)

Xinyi City People's Hospital

Xingyi, Guangdong, China

RECRUITING

Universiti Sains Malaysia

George Town, Pulau Pinang, 11800, Malaysia

NOT YET RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sitao Li, MD.

  The Sixth Affiliated Hospital of Sun Yat-sen University, Xinyi People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min-Tze Liong, Ph.D.

CONTACT

6046532114; mintze.liong@usm.my

Jie Yuan, M.Sc.

CONTACT

822137027899; peanut.yuan@diprobio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 22, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 17, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); MY (1)