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Female Urogenital Nutrition- Health Study (FUN-Health)

Primary Purpose

Bacterial Urinary Tract Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Plain Water
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Urinary Tract Infection

Eligibility Criteria

18 Years - 34 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female
  • 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

Exclusion Criteria:

  • Males
  • 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

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fluid Increase

Fluid Habitual

Arm Description

The increased fluid intervention arm will begin on day 2 after the onset of bleeding (day 1) of their phase 1 menses through day 5. For the increased fluid intake intervention, participants will a) consume an additional 64 oz (1.89 L) of plain water only on top of habitual fluid intake and b) aim to at least urinate 5 times per day.

The fluid habitual non-intervention arm will a) maintain normal fluid intake volume and beverage choices and a) urination frequency.

Outcomes

Primary Outcome Measures

Uropathogenic Bacterial Activity
Number of bacterial colonies and uropathogens found

Secondary Outcome Measures

Hydration Status
Urine concentration via urine specific gravity

Full Information

First Posted
August 9, 2021
Last Updated
May 2, 2022
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT05015400
Brief Title
Female Urogenital Nutrition- Health Study
Acronym
FUN-Health
Official Title
Female Urogenital Nutrition- Health Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 5, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Urinary Tract Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluid Increase
Arm Type
Experimental
Arm Description
The increased fluid intervention arm will begin on day 2 after the onset of bleeding (day 1) of their phase 1 menses through day 5. For the increased fluid intake intervention, participants will a) consume an additional 64 oz (1.89 L) of plain water only on top of habitual fluid intake and b) aim to at least urinate 5 times per day.
Arm Title
Fluid Habitual
Arm Type
No Intervention
Arm Description
The fluid habitual non-intervention arm will a) maintain normal fluid intake volume and beverage choices and a) urination frequency.
Intervention Type
Other
Intervention Name(s)
Plain Water
Intervention Description
To increase water fluid intake, an additional 1.89 L, during phase 1 of the menstrual cycle (days 1-5).
Primary Outcome Measure Information:
Title
Uropathogenic Bacterial Activity
Description
Number of bacterial colonies and uropathogens found
Time Frame
Change from Baseline Uropathogenic Bacterial Activity at 1 month
Secondary Outcome Measure Information:
Title
Hydration Status
Description
Urine concentration via urine specific gravity
Time Frame
Change from Baseline Hydration Status at 1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female 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 Exclusion Criteria: Males 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaila A Vento, PhD(c)
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
Starting 6 months after publication.

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Female Urogenital Nutrition- Health Study

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