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临床试验/CTRI/2025/11/097860
CTRI/2025/11/097860尚未招募4 期

Effect of probiotics on duration of acute febrile illness in hospitalized pediatric patients, randomized, double blind placebo controlled study.

DR SHAILESH SALUNKHE1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月4日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1.To determine fever duration

研究概览

简要总结

Acute febrile illnesses (AFIs) are a major cause of pediatric hospital admissions worldwide, leading to prolonged stays and high healthcare costs. While supportive and antimicrobial care are standard, probiotics—known for their immune and gut-modulating properties—may help shorten illness duration. However, hospital-based evidence in children remains limited.

This randomized, double-blind, placebo-controlled trial aims to evaluate the effect of probiotics on the duration of acute febrile illness in hospitalized children (1–18 years). Fifty participants will be randomized into two groups:

Intervention group: receiving a probiotic mixture (Lactobacillus acidophilus, L. rhamnosus, Bifidobacterium longum, Bacillus coagulans, and Saccharomyces boulardii).Control group: receiving an identical placebo (maltodextrin).

Primary outcomes: fever duration and total illness duration. Secondary outcome: any adverse effects.

Eligible children are those hospitalized with AFI and without chronic or immunosuppressive conditions. The study will run for six months after ethics approval, with no external funding or follow-up period.

This study seeks to fill an important research gap by providing evidence on whether probiotic supplementation can safely and effectively reduce fever duration and recovery time in hospitalized pediatric patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
1.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Child hospitalized with acute febrile illness Patient/ Parents willing to participate.

排除标准

  • Recent use of probiotics in preceding 2 weeks Any autoimmune illness, any chronic illness Patient on immunosuppressive treatment.

结局指标

主要结局

1.To determine fever duration

时间窗: 1.Baseline | 2.7 days | 3. At the recovery of the patient

2.To determine duration of illness

时间窗: 1.Baseline | 2.7 days | 3. At the recovery of the patient

次要结局

  • To determine any adverse effects(1. Baseline)

研究者

发起方
DR SHAILESH SALUNKHE
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Salunkhe Shailesh

Ruby Hall Clinic

研究点 (1)

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