Using probiotics to improve gut health in children with respiratory symptoms
Modulation of Gut Microbiota by Probiotic in Children With Respiratory Symptoms
NA · Universiti Sains Malaysia · NCT05794815
This study tests if giving preschool children with respiratory symptoms a probiotic drink can help improve their gut health and reduce the number of respiratory infections they get.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 12 Months to 7 Years |
| Sex | All |
| Sponsor | Universiti Sains Malaysia (other) |
| Locations | 1 site (Cheras, Kuala Lumpur) |
| Trial ID | NCT05794815 on ClinicalTrials.gov |
What this trial studies
This project investigates the effects of the probiotic Bifidobacterium infantis YLGB-1496 on gut microbiota in preschool children aged over 12 months and under 7 years who exhibit respiratory symptoms. The study compares children receiving probiotic-infused milk to those receiving a control milk without probiotics. It aims to determine whether probiotics can reduce the incidence of respiratory infections and associated complications, as well as decrease the need for antibiotic treatments. The research focuses on children in daycare settings, where the risk of respiratory illnesses is heightened due to close contact.
Who should consider this trial
Good fit: Ideal candidates for this study are preschool children aged over 12 months and under 7 years who are experiencing respiratory symptoms.
Not a fit: Patients with long-term medication use, chronic diseases, or gastrointestinal malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a novel approach for preventing respiratory infections in young children, potentially reducing illness and antibiotic use.
How similar studies have performed: Previous studies have shown promising results regarding the use of probiotics in preventing respiratory infections, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preschool children (\>12 months old, \<7 years old). * Having respiratory symptoms (having at least two of the following signs and symptoms: fever (even if only reported not measured), nasal obstruction, chills, sore throat, headache, cough, runny nose, olfactory disturbances, or taste disturbances; Pucarelli-Lebreiro et al., 2022). * Healthy with current weight of P20-P80 percentile chart of children * Infant formula powder does not contain probiotics; prebiotics FOS is not allowed, GOS \<2g/ 100g is allowed * Willing to commit throughout the experiment Exclusion Criteria: * Long term medication \>6 months for any diseases * Deformity * Mothers with metabolic and/or chronic diseases * Current or previous diseases, conditions or interventions that may interfere with the study (such as tolerance and/or growth and development), such as gastrointestinal malformations, chronic diarrhea, malabsorption syndromes, malnutrition, congenital immunodeficiency or surgery * Oral antibiotics within 2 weeks before the intervention * Nutritional supplements containing probiotics and prebiotics (except infant formula) within 2 weeks before the intervention * Foods for special medical purposes or non-standard formula powders for lactose intolerance and galactosemia * Probiotic allergies or possible food allergies (milk, etc.) * Participated in other clinical studies 4 weeks before the intervention * Unwilling to participate for any particular reason
Where this trial is running
Cheras, Kuala Lumpur
- UKM Medical Centre — Cheras, Kuala Lumpur, Malaysia (RECRUITING)
Study contacts
- Principal investigator: Adli Ali, MD — National University of Malaysia
- Study coordinator: Adli Ali, MD
- Email: adli.ali@ppukm.ukm.edu.my
- Phone: 603 8921 5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Infection, probiotic, respiratory tract infections, Bifidobacterium, children