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临床试验/NCT06323642
NCT06323642招募中不适用

Role of Probiotics as Adjunct Therapy Along With Standard Care in Decreasing Hospital Stay and Improving Symptoms in Pediatric Patients Admitted With Severe Pneumonia

Shaheed Zulfiqar Ali Bhutto Medical University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Number of days in hospital

研究概览

简要总结

Probiotics as adjuvant therapy along with standard care can decrease hospital stay and improve symptoms (fever, tachypnea,cough) in pediatric patients admitted with severe pneumonia.

详细描述

After getting written informed consent from parents/attendants, all patients aged 6 month-2yrs admitted with severe pneumonia in pediatric wards of children hospital, during the study time of 6 month will be recruited.After applying exclusion criteria remaining participants will be included in the study. The study population will be randomized in to two groups, Group A will be given probiotic sachet and group B will be given simple milk as placebo.The patients and their parents/attendants will be kept blind to the fact that they are receiving either probiotic or placebo The probiotic and placebo mixture will be given daily for three days.The patients in both the groups will be followed for the duration of illness until they are either discharged or show any adverse outcomes of pneumonia.Total days of admission will be recoded for patients discharged from hospital.Parents will be asked questions regarding improvement in symptoms like fever on discharge. Duration for Improvement in tachypnea andcough will be noted for all patients. Outcomes will be duration of hospital admission, improvement in fever, tachypnea and cough.All the data collected will be entered and analyzed using SPSS latest version and analysed.

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
Single (Participant)

盲法说明

The patients and their parents/attendants will be kept blind to the fact that they are receiving either probiotic or placebo

入排标准

年龄范围
6 Months 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patients with severe acute malnutrition Patients with very severe pneumonia Patients with Other concurrent infections Patients having any chronic debilitating condition Children who took probiotics in past 6 months Patient requiring mechanical ventilation

研究组 & 干预措施

A

Experimental

probiotic mixture will be given daily to patients probiotic mixture containing: Lactobacillus rhamnosus GG

干预措施: probiotic containing Lactobacillus rhamnosus GG. (Dietary Supplement)

B

Placebo Comparator

placebo mixture will be given to patients with pneumonia

干预措施: placebo (Other)

结局指标

主要结局

Number of days in hospital

时间窗: 6 month

hospital stay in patients admitted with severe pneumonia.

次要结局

  • Number of days with cough, fever(6 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Nighat Haider

assisstant professor

Shaheed Zulfiqar Ali Bhutto Medical University

研究点 (2)

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