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Not Yet Recruiting NCT07399717

Assessing Role of Probiotics in Children Aged 6-36 Months Treated for Pneumonia

Conditions: Pneumonia, Pneumonia in Children

Sex: All
Ages: 6 Months – 36 Months
Healthy volunteers: No
Phase: NA
Enrollment: 330
Sponsor: Anabio R&D

Location: Phu Tho Provincial Obstetrics and Pediatrics Hospitals Phú Thọ

Summary

The main questions this study aims to answer are: * Does using probiotic nasal spray (LiveSpo Navax containing Bacillus subtilis and Bacillus clausii, 1x10\^9 CFU/mL), with or without oral probiotics (LiveSpo Pregmom containing Bacillus subtilis, Bacillus clausii, and Bacillus coagulans, 3x10\^9 CFU/5 mL), help children recover better from pneumonia when added to standard medical treatment? * Does using these adjunctive probiotics support reduce the recurrence of respiratory and gastrointestinal symptoms after hospital discharge? Researchers will compare three groups of children to see whether probiotic nasal spray alone or probiotic nasal spray combined with oral probiotics works better than placebo. All participants will receive standard medical treatment for pneumonia. In addition, they will be randomly assigned to one of three study groups to receive adjunctive probiotic support in 2 months: * Control group: receives a saline nasal-throat spray (0.9% NaCl) and oral placebo liquid (RO water). * Nasal probiotic group: receives a probiotic LiveSpo® Navax nasal-throat spray and oral placebo liquid (RO water). * Nasal plus oral probiotic group: receives a probiotic LiveSpo® Navax nasal-throat spray plus LiveSpo® Preg-Mom oral probiotic suspension. Participants will: * Use a nasal-throat spray three times a day. * Take an oral liquid twice daily. * Start using the study products during their hospital stay and continue for 8 weeks (2 months) from admission. * Be followed by the study team during hospitalization and at Day 30 and Day 60 after admission. The probiotic and placebo products look, smell, and taste the same so that neither the parents nor the study staff know which product each child receives.

Eligibility Criteria

Inclusion Criteria: * Children (male/female) aged 6-36 months diagnosed and hospitalized for treatment for pneumonia. * Parents or guradians of the children agree to participate in the study, explain, and sign the research consent form. Exclusion Criteria: * Children who need ventilator support. * Children who have had rhinoplasty surgery, nasal ulcers, nasal polyps or any nasal deformity that affects the use of the study product. * Children who get transferred or leave the treatment unit (not for professional reasons). * Children who have experienced congenital immunodeficiency or infectious disease (eg, HIV). * Children who are concurrently participating in another clinical trial or participated in a clinical trial within 30 days before selection. * Children who are under long-term medication (more than 7 consecutive days) within 30 days before selection. * Children with allergy or hypersensitivity to any ingredient of the study product.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07399717). StuddyBuddy aggregates publicly available trial information.