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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-36
SponsorAnabio R&D

About this trial

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

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Placebo
  • Navax
  • Navax-PregMom

Treatment groups

330 Participants
are divided into 3 treatment groups

Sponsors and collaborators