跳至主要内容
临床试验/NCT06125626
NCT06125626已完成2 期

Prevention of Traveler's Diarrhea While Crossing the Amazon Forest by Bike With a Supplement Based on Lacticaseibacillus Rhamnosus LR04 + Streptococcus Thermophilus FP4 + Bifidobacterium Brevis BR03: a Phase Two, Randomized, Placebo-controlled, Double-blind, Cross-over Pilot Study

University of Palermo2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2023年7月10日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
3
试验地点
2
主要终点
Incidence of diarrhea

研究概览

简要总结

The prevention of traveller's diarrhea makes use of the selection of foods and drinks, the purification of water, the use of pharmacological substances such as bismuth salicylate and rifaximin (which can only be taken for short periods). The very attractive prospect of preventing travellers' diarrhea without systemic antibiotics has fueled interest in probiotics for this purpose. However, not all probiotics are identical, and the results of studies conducted with a particular agent cannot be generalized to indicate that any probiotic agent would be successful in the same clinical situation. Probiotics such as Lactobacillus GG have been shown to reduce the incidence of diarrhea in travelers in randomized controlled trials. In contrast, another Lactobacillus preparation, non-viable Lactobacillus acidophilus, showed no benefit over placebo in a randomized, double-blind, controlled trial of 174 travelers. The reasons for this are unclear, but could be related to the fact that the bacteria were not viable or a peculiarity of the strain selected for testing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
Male
接受健康志愿者

入选标准

  • Healthy bikers
  • Able to pass the Amazonia forest by bike

排除标准

  • None predifinied

结局指标

主要结局

Incidence of diarrhea

时间窗: 12 weeks

Diarrhea will be defined using the Bristol's scale (value of 7) in a scale between 1 and 7, higher values reflecting more diarrhoic attitude

次要结局

  • Mean quality of life(12 weeks)
  • Incidence of severe diarrhea(12 weeks)

研究者

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

Nicola Veronese

Professor

University of Palermo

研究点 (2)

Loading locations...

相似试验