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临床试验/NCT05015400
NCT05015400已完成不适用

Female Urogenital Nutrition- Health Study

Arizona State University2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2021年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Uropathogenic Bacterial Activity

研究概览

简要总结

The purpose of this study is to assess nutrition and urinary tract bacterial activity during menstruation of approximately 15 female university Reserve Officer Training Corps (ROTC) cadets and Phoenix area police officers, firefighters, and military veterans.

详细描述

Urinary tract infections (UTIs) disrupt tactical service women's obligations and health, which increases sexual transmitted infections (STIs), HPV, and cervical cancer risk if left untreated. Females are more susceptible to UTIs due to their unique anatomical features and hormone fluctuations affecting vaginal flora. During phase 1 of the menstrual cycle (i.e., onset of bleeding, menstrual cycle days 1-5), estrogen levels significantly decrease and inhibit the growth of lactobacilli (good bacteria), which is essential in warding off bad bacteria and infections, particularly UTIs. The uropathogenic bacterial growth in phase 1 could be heightened in phase 2 of the menstrual cycle (i.e., leading to ovulation), as increases in estrogen favors bacteria adhesion and arginine vasopressin (AVP) release that stimulates fluid retention, leading to less volume flow in the urinary tract. To reduce UTI onset, it is recommended to frequently urinate with sufficient urine void volume to facilitate washing out harmful bacteria from the urethra and bladder. While menstruating, increased fluid consumption to support urination frequency and void volume may be critical, as the urinary tract is more predisposed to infections, and the effects of estrogen on bacterial adhesion and AVP release in phase 2 could continue uropathogenic growth.

Question(s) 1: Are premenopausal tactical service women's current hydration status and behaviors (i.e., fluid intake and urination) sufficient? How many premenopausal tactical service women have a UTI history?

Question 2: Will increasing daily water intake of identified underhydrated tactical service women reduce uropathogenic bacterial activity during the first part (i.e., onset of bleeding through day 5) of the menstrual cycle?

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
Single (Participant)

入排标准

年龄范围
18 Years 至 34 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-34 years of age or older (premenopausal)
  • Have a 21-35-day menstrual cycle
  • No changes in hormonal contraceptives within the last three months
  • No current UTI symptoms
  • Sexual activity and inactivity

排除标准

  • Under 18 years of age or over 34 years of age
  • Pregnant or nursing
  • Menstrual irregularities effecting having a menstrual cycle to be between 21-35 days
  • Progesterone-only contraceptive use (combined estrogen-progesterone and non-hormonal IUDs are okay)
  • Currently taking antibiotics
  • On hormone replacement therapy
  • Currently experiencing symptomatic vulvovaginitis
  • Diagnosed with recurrent UTI
  • Not volunteering to participate

结局指标

主要结局

Uropathogenic Bacterial Activity

时间窗: Change from Baseline Uropathogenic Bacterial Activity at 1 month

Number of bacterial colonies and uropathogens found

次要结局

  • Hydration Status(Change from Baseline Hydration Status at 1 month)

研究者

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

Kaila Vento

Principal Investigator

Arizona State University

研究点 (2)

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