Efficacy and Safety of Lactobacillus Plantarum and Pediococcus Acidilactici as Twice-daily Co-adjuvant Therapy of Upper Respiratory Tract Infections in Children 6 Months to 5 Years Old
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Daily evolution of fever
研究概览
简要总结
Randomized, placebo-controlled trial to evaluate the coadjuvant effect of a combination of L. plantarum and P. acidilactici probiotic strains, taken twice daily, in children 6 months to 5 years-old with upper respiratory tract infections with pharyngitis and/or tonsillitis. Main objective is to evaluate efficacy of this probiotic in reducing fever and pain, as well to evaluate its safety.
详细描述
Randomized, placebo-controlled trial (RCT) to evaluate the coadjuvant effect of probiotic strains L. plantarum CECT30292, L.plantarum CECT7484 and CECT7485 together with P. acidilactici CECT7483, taken twice daily, in children 6 months to 5 years-old with upper respiratory tract infections with pharyngitis and/or tonsillitis, as diagnosed by a physician.
Main objective is to evaluate efficacy of this probiotic in reducing fever (as per infrared thermometer, same model for all recruited subjects) and pain (as per FLACC scale [Face, Legs, Activity, Cry and Consolability]), as well to evaluate its safety. Secondary objectives include effect on cough, rhinorrhea, nasal congestion, use of concomitant medication, emergency visits, hospitalizations, schooling absences and salivary immune markers.
Probiotic intervention will last 15 days, and patients will return for follow-up visits on the last day of probiotic intervention (day 15), and well as day 30 and 60.
The study aims at enrolling and randomizing 80 children fulfilling entry criteria and living in Mexico City area (2,200m over the sea level), after parents or legal guardians sign informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All study staff, including the Principal Investigator and the persons performing the subject assessments, will be blinded during the study. Sealed individual treatment code envelopes will be kept at the clinic to be able to break the code if any emergency occurs, as judged by the Investigator
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female children, 6 months to 5 years-old
- •Diagnosed with upper respiratory tract infection with pharyngitis and/or tonsillitis by a physician
- •With fever >37.5 Celsius degrees and FLACC (Face, Legs, Activity, Cry and Consolability) score >3
- •Symptom onset no more than 48h before study entry
- •Body weight at birth >2500 gr
- •Informed consent provided by parents or legal guardians
排除标准
- •Failure to thrive
- •Asthma or significant allergic disease
- •Use of antibiotics, antivirals, probiotics or prebiotics for more than 48h within 2 weeks of study entry
- •History of recurrent respiratory infections (>2 otitis, >1 severe sinusitis or >1 pneumonia) within 12 months of study entry
- •History of 2 or more invasive infections (meningitis, cellulitis, osteomyelitis, sepsis)
- •Chronic diarrhea or short bowel syndrome
- •Congenital heart or respiratory deficiency
- •Known alpha1-antitrypsin deficiency
- •Concurrent participation in other clinical trial(s)
- •Other particular conditions which, in the judgment of the Principal Investigator, may interfere with the study
结局指标
主要结局
Daily evolution of fever
时间窗: Day 1 to 15
Daily severity of fever (Celsius degrees), as measured with an infrared thermometer (same model for all recruited subjects) and noted in patient diary
Daily evolution of pain
时间窗: Day 1 to 15
Daily severity of pain, as per FLACC scale (Face, Legs, Activity, Cry and Consolability, ranging 0 \[no pain\] to 10 \[maximum pain\]) and noted in patient diary
次要结局
- Time to complete symptom resolution(Day 1 to 15)
- Time to fever recurrence(Day 15 to 60)
- Time to pain recurrence(Day 15 to 60)
- Days with cough(Day 1 to 60)
- Change in salivary immune biomarkers(Day 1 to 15)
- Days with nasal congestion(Day 1 to 60)
- Change in microbiota(Day 1 to 15)
- Number of hospitalizations(Day 1 to 60)
- Number of medical or emergency visits(Day 1 to 60)
- Time to fever resolution(Day 1 to 15)
- Time to any symptom recurrence(Day 15 to 60)
- Fever Area Under the Curve(Day 1 to 60)
- Pain Area Under the Curve(Day 1 to 60)
- Days with fever(Day 1 to 60)
- Days with pain(Day 1 to 60)
- Days with rhinorrhea(Day 1 to 60)
- Days with any symptom(Day 1 to 60)
- Total treatment costs(Day 1 to 60)
- Time to pain resolution(Day 1 to 15)
- Days with concomitant medication(Day 1 to 60)
- Number of children receiving antibiotics(Day 1 to 60)
- Days of schooling absence(Day 1 to 60)