Assessing Role of Probiotics in Children Aged 6-36 Months Treated for Pneumonia at Phu Tho Provincial Obstetrics and Pediatrics Hospitals Within 2026-2027
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Anabio R&D
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Number of days with typical clinical symptoms of pneumonia
研究概览
简要总结
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.
详细描述
This study is a randomized, double-blind, placebo-controlled clinical trial conducted at Phu Tho Provincial Obstetrics and Pediatrics Hospital to evaluate Bacillus spore probiotics delivered by nasal-oropharyngeal spray (LiveSpo® Navax) with or without an oral probiotic suspension (LiveSpo® Preg-Mom) as an adjunct to standard medical treatment in children aged 6-36 months hospitalized with pneumonia.
A total of 330 eligible children will be randomly assigned in a 1:1:1 ratio into three groups (n = 110 per group):
the Control group receiving 0.9% sodium chloride nasal-oropharyngeal spray and oral RO water, the Navax group receiving Bacillus spore probiotic nasal-oropharyngeal spray and oral RO water, and the Navax-PregMom group receiving Bacillus spore probiotics both as nasal spray and oral suspension. All participants receive standard-of-care treatment according to hospital guidelines, with differences between groups limited to the assigned study interventions.
The nasal-oropharyngeal spray is administered as three sprays per nostril and throat per dose, three times daily, and the oral intervention is administered at a daily dose of 5 mL, twice daily. Interventions are initiated during hospitalization and continued for up to two months from admission.
Rationale and need: Pediatric pneumonia often proceeds upper-airway infection and is characterized by pathogen colonization of-and inflammation within the naso-/oropharyngeal mucosa. Accordingly, a nasal-throat Bacillus spore spray could serve as a local adjunct to maintain airway hygiene and mucosal restitution while potentially mitigating the load of respiratory viruses and bacterial co-pathogens at the site of infection. Concomitant interventions for hospitalized children with pneumonia, including supportive care and administration of medications (such as antibiotics), could perturb the gut microbiota and lead to gastrointestinal symptoms before or after treatment. An oral Bacillus spore suspension is expected to complement the local intervention by acting through the gut-immune interface, thereby supporting systemic immune modulation and recovery beyond the upper airway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
LiveSpo Navax and placebo 0.9% NaCl physiological saline are indistinguishable regarding taste and smell. The color and turbidity of LiveSpo Navax suspension are unrecognizable to investigators, trainers, child caregivers, children's parents, and children due to opaque plastic container. Similarly, LiveSpo Preg-Mom and oral reverse osmosis (RO) water were matched in sensory characteristics and packaging, thereby maintaining blinding of investigators, caregivers, parents, and participants.
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
The placebo group receives 0.9% NaCl physiological saline. Caregivers will spray the children three times daily, administering 3 sprays in each nostril and 3 sprays in the throat each time (totally 6 sprays each time) for 8 weeks.
The placebo group also receives oral Reverse Osmosis water twice daily, 5 mL per dose, for 8 weeks The Placebo group receives standard pneumonia treatment: oxygen (SpO2 < 92%) and antibiotics (ampicillin/sulbactam, with or without aminoglycosides/third-generation cephalosporins). Vancomycin/macrolides cover staphylococcal/atypical agents; levofloxacin is an alternate. Adjust per antibiogram. Supportive care: antipyretics, suctioning, fluids/electrolytes, nutrition, physiotherapy. Bronchodilators/corticosteroids are used for bronchospasm or severe pneumonia.
干预措施: Placebo (Other)
Navax
The Navax group receives LiveSpo® Navax product, which is NaCl 0.9% plus B. subtilis and B. clausii at 1 billion CFU/mL x 30 mL. Caregivers will spray the children three times daily, administering 3 sprays in each nostril and 3 in the throat, for 8 weeks.
The Navax group also receives oral RO water twice daily, 5 mL per dose, for 8 weeks.
The Navax group receives standard pneumonia treatment: oxygen (SpO2 < 92%) and antibiotics (ampicillin/sulbactam, with or without aminoglycosides/third-generation cephalosporins). Vancomycin/macrolides cover staphylococcal/atypical agents; levofloxacin is an alternate. Adjust per antibiogram. Supportive care: antipyretics, suctioning, fluids/electrolytes, nutrition, physiotherapy. Bronchodilators/corticosteroids are used for bronchospasm or severe pneumonia.
干预措施: Navax (Combination Product)
Navax-PregMom
The Navax-PregMom group receives LiveSpo® Navax product which is NaCl 0.9% plus B. subtilis and B. clausii at 1 billion CFU/mL x 30 mL. Caregivers will spray the children three times daily, administering 3 sprays in each nostril and 3 sprays in the throat each time for 8 weeks.
The Navax-PregMom group is also given oral medication with LiveSpo® Preg-Mom which is RO water plus B. subtilis, B. clausii, and B. coagulans at 3 billion CFU/5mL. The children will receive the probiotic twice daily, with 1 vial per dosefor 8 weeks.
The Navax-PregMom group receives standard pneumonia treatment: oxygen (SpO2 < 92%) and antibiotics (ampicillin/sulbactam, with or without aminoglycosides/third-generation cephalosporins). Vancomycin/macrolides cover staphylococcal/atypical agents; levofloxacin is an alternate. Adjust per antibiogram. Supportive care: antipyretics, suctioning, fluids/electrolytes, nutrition, physiotherapy. Bronchodilators/corticosteroids are used for bronchospasm or severe pneumonia.
干预措施: Navax-PregMom (Combination Product)
结局指标
主要结局
Number of days with typical clinical symptoms of pneumonia
时间窗: Daily assessments will be conducted during hospitalization, from admission (Day 0) through discharge. The duration of hospitalization is variable, averaging 10 days.
Symptoms to be assessed include fever, cough, tachypnea, chest retraction, wheezing, crackles, moist rales, diarrhea, etc.
Number of days of inpatient treatment
时间窗: Daily assessments will be conducted during hospitalization, from admission (Day 0) through discharge. The duration of hospitalization is variable, averaging 10 days.
The total number of days a participant stays in the hospital for treatment during the study period.
次要结局
- Use of medications and supportive treatments during hospitalization(Daily assessments will be conducted during hospitalization, from admission (Day 0) through discharge. The duration of hospitalization is variable, averaging 10 days.)
- Inflammatory cytokine and IgA levels in clinical samples(Days 0 and 3 (mandatory), and on discharge days 30 and 60 (optional))
- Presence of probiotic bacterial spores(Days 0 and 3 (mandatory), and on discharge days 30 and 60 (optional))
- Semi-quantitative changes in respiratory viral and bacterial pathogen loads(Days 0 and 3 (mandatory), and on discharge days 30 and 60 (optional))
- Proportion of children with diarrheal symptoms during hospitalization(Daily assessments will occur during hospitalization, from admission (Day 0) until discharge. The duration of hospitalization is variable, averaging 10 days.)
- Recurrence of acute respiratory and gastrointestinal symptoms(Day 30 and/or day 60 of the study)
- Hospital readmission due to respiratory and gastrointestinal illnesses(Day 30 and/or day 60 of the study)
- Use of Medications During Follow-up(Day 30 and/or day 60 of the study)
- IgA levels in stool samples(Time Frame: Days 0 and 3 (mandatory), and on discharge days 30 and 60 (optional))