Evaluation of the Clinical Efficacy of Antrrix Probiotics in Improving Recurrent Respiratory Infections in Infants and Young Children
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-6
SponsorMin-Tze LIONG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotic
Dietary supplementDaily 2 × 10 9 CFU per 6 drops containing Lactobacillus rhamnosus CRL1505+Bifidobacterium brevis M-16V strain in MCT oil
Placebo
Dietary supplementDaily 6 drops MCT oil without probiotics
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: ProbioticExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
day 1, day 7, day 14, week 4, week 8Secondary outcomes
1
Quality of life in children upon administration of probiotic or placebo via clinical questionnaire
Differences in quality of life in children upon administration of probiotic or placebo, assessed using a hospital-based caregiver-reported clinical questionnaire scored on a 5-point ordinal scale, with lower scores indicating better quality of life.
Time frame
day 1, day 7, day 14, week 4, week 82
Microbiota profiles of fecal samples in young children upon administration of probiotic, lactulose or their combinations as assessed via metagenomics sequencing
Differences in microbiota profiles in fecal sample of children upon administration of probiotic or placebo
Time frame
day 1, day 7, day 14, week 4, week 83
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)
Differences in immune biomarker profiles in fecal sample of children such as sIgA upon administration of probiotic or placebo
Time frame
day 1, day 7, day 14, week 4, week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Min-Tze LIONG
Lead sponsor
Universiti Sains Malaysia
Sponsor institution
Xinyi City People's Hospital
Collaborator
Source ClinicalTrials.gov