Bacterial Urinary Tract InfectionFUN-HealthNCT05015400
Female Urogenital Nutrition- Health Study
A study testing Plain Water in people with Bacterial Urinary Tract Infection, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Urinary Tract Infection
- What is being tested?
- Plain Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- On hormone replacement therapy
- Currently experiencing symptomatic vulvovaginitis
- Diagnosed with recurrent UTI
- Not volunteering to participate
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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?
- Conditions
- Bacterial Urinary Tract Infection
- Being tested
- Plain Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plain WaterOther
To increase water fluid intake, an additional 1.89 L, during phase 1 of the menstrual cycle (days 1-5).
| Study group | Role | What they receive |
|---|---|---|
| Fluid Increase | Experimental | 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. Receives: Other: Plain Water |
| Fluid Habitual | No intervention | The fluid habitual non-intervention arm will a) maintain normal fluid intake volume and beverage choices and a) urination frequency. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uropathogenic Bacterial Activity
Number of bacterial colonies and uropathogens found
Measured: Change from Baseline Uropathogenic Bacterial Activity at 1 month
Secondary outcomes (1)
Hydration Status
Urine concentration via urine specific gravity
Measured: Change from Baseline Hydration Status at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start5 Sep 2021
- Primary completion15 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaila Vento, Arizona State University
- Investigators
- Kaila A Vento, PhD(c), Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015400
- Sponsor's protocol ID
- STUDY00014289
- Acronym
- FUN-Health
- Status last verified
- May 2022
- First submitted
- 9 Aug 2021
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female Urogenital Nutrition- Health Study
- ClinicalTrials.gov ID
- NCT05015400
- Acronym / sponsor ID
- FUN-Health / STUDY00014289
- Conditions
- Bacterial Urinary Tract Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluid Increase | Experimental | Other: Plain WaterThe 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. |
| Fluid Habitual | No intervention | –The fluid habitual non-intervention arm will a) maintain normal fluid intake volume and beverage choices and a) urination frequency. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plain WaterTo increase water fluid intake, an additional 1.89 L, during phase 1 of the menstrual cycle (days 1-5). | Other | Fluid Increase |
Primary outcome
Uropathogenic Bacterial Activity
Time frame: Change from Baseline Uropathogenic Bacterial Activity at 1 month
Number of bacterial colonies and uropathogens found
1 secondary outcome
Hydration Status
Time frame: Change from Baseline Hydration Status at 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Evaluate of the Use of Uromune as a Potential Non-antibiotic Prophylactic Strategy for Catheter-associated Urinary Tract Infection in Patients With Long-term Catheterization.
Catheter-Associated Urinary Tract Infections (CAUTIs)
Not yet recruitingObservational study
Prevalence of Asymptomatic Bacteriuria Among Pregnant Women With Pre-eclampsia in Women Health Hospital Assiut University
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaila A Vento, PhD(c) principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plain Water in people with Bacterial Urinary Tract Infection, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uropathogenic Bacterial Activity (time frame: Change from Baseline Uropathogenic Bacterial Activity at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.