Urinary Tract InfectionNCT01219595
Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women
A study testing Sweetened, dried cranberries, Strawberry Fruit Pieces and Observation in people with Urinary Tract Infection, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of the research is to determine if eating sweetened, dried cranberries or strawberry fruit pieces will increase the types of different E. coli bacteria in the intestines which may reduce the likelihood of a major, or highly harmful urinary type of bacteria which cause urinary tract infections in… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Sweetened, dried cranberries, Strawberry Fruit Pieces and Observation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2012
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women, ages 18-65
- History of recurrent urinary tract infections defined as three in the past year, or two in the last six months
- Subjects must be willing to follow the study protocol that includes consuming the mandatory daily dose of cranberries or strawberry fruit pieces and traveling to the UWHC Urology clinic for scheduled rectal and vaginal swab procedures.
- The non-UTI-susceptible group will include women ages 18-65 with no history of recurrent UTI's as defined above.
Who cannot join
- Women who:
- Are pregnant
- Have an immune compromising disease
- Have diabetes
- Have kidney stones
- Have chronic bowel inflammatory disease
- Have known allergies to cranberries, strawberries, elderberries, or wheat fiber
- Non-UTI-susceptible group will include women ages 18-65 with no history of recurrent UTI's as defined above.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53792
About this study
The purpose of the research is to determine if eating sweetened, dried cranberries or strawberry fruit pieces will increase the types of different E. coli bacteria in the intestines which may reduce the likelihood of a major, or highly harmful urinary type of bacteria which cause urinary tract infections in susceptible women.
Read the detailed description
This is a research study about the number and types of bacteria that cause urinary tract infections (E. coli strains) that are present in the intestine. The bacteria will be collected and analyzed before and after eating either sweetened, dried cranberries or strawberry fruit pieces. This study will help us learn more about whether or not the components of consumed sweetened, dried cranberries or strawberry fruit pieces reduce the numbers of harmful E. coli bacteria in the vaginal and intestinal tracts, thereby reducing the number of urinary tract infections among women.
- Conditions
- Urinary Tract Infection
- Being tested
- Sweetened, dried cranberries, Strawberry Fruit Pieces, Observation
- Keywords
- Urinary Tract Infection, UTI
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweetened, dried cranberriesOther
Women in Arm 1 will consume one serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.
Strawberry Fruit PiecesOther
1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for three separate, two-week periods. Each two week period will be separated by a two-week interval.
Sweetened, dried cranberriesOther
1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for three separate, two-week periods. Each two week period will be separated by a two-week interval.
Sweetened, dried cranberriesOther
1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.
Strawberry Fruit PiecesOther
1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.
ObservationOther
Subjects in the non-UTI susceptible group will have one visit where one vaginal and one rectal swab will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Active comparator | 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks. Receives: Other: Sweetened, dried cranberries |
| No treatment | Other | 20 non-UTI susceptible women will be enrolled to collect data on the types of E. coli flora present in non-UTI women. Receives: Other: Observation |
| Part 2A | Active comparator | 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for three separate, two-week periods. Each two week period will be separated by a two-week interval. Receives: Other: Sweetened, dried cranberries |
| Part 2B | Placebo comparator | 1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for three separate, two-week periods. Each two week period will be separated by a two-week interval. Receives: Other: Strawberry Fruit Pieces |
| Part 3A | Active comparator | 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period. Receives: Other: Sweetened, dried cranberries |
| Part 3B | Placebo comparator | 1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period. Receives: Other: Strawberry Fruit Pieces |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-treatment heterogeneity or prevalence
- Prevalence or heterogeneity of E. coli strains in UTI susceptible women pre-treatment
Measured: Day 1 - prior to start of study treatment
Post-treatment heterogeneity
- a change in the heterogeneity of strains post treatment
Measured: 2 weeks, 1 month, or 3 months
Patient acceptance of study regimen
- patient acceptance of the study regimen
Measured: 2 weeks, 1 month, or 3 months
Maintenance of heterogeneity in the intestinal flora
To determine whether a shift towards strain heterogeneity in the intestinal flora can be maintained over a three month period.
Measured: Approximately 3 months
Measure Effects of sweetened, dried cranberries on E. coli clonotypes over three two-week exposures
Measure effects of sweetened, dried cranberries on E. coli clonotypes over three two-week exposures
Measured: Approximately 3 months
Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure
Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure
Measured: 2 weeks, 1 month, or 3 months
Measure the UTI recurrence
Measure the UTI recurrence after 6 months from the beginning of the study.
Measured: 2 weeks, 1 month, or 3 months
Comparison of sweetened dried cranberries to a placebo group
Comparison of sweetened dried cranberries to a placebo group (strawberry fruit pieces)
Measured: 2 weeks, 1 month, or 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Ocean Spray Cranberries, Inc.
- Responsible party
- Sponsor
- Investigators
- Walter Hopkins, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219595
- Sponsor's protocol ID
- H-2010-0107
- Status last verified
- Jan 2016
- First submitted
- 8 Oct 2010
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women
- ClinicalTrials.gov ID
- NCT01219595
- Acronym / sponsor ID
- H-2010-0107
- Conditions
- Urinary Tract Infection
- Keywords
- Urinary Tract Infection, UTI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Ocean Spray Cranberries, Inc.
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 13 Oct 2010 (estimated)
- 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 the research is to determine if eating sweetened, dried cranberries or strawberry fruit pieces will increase the types of different E. coli bacteria in the intestines which may reduce the likelihood of a major, or highly harmful urinary type of bacteria which cause urinary tract infections in susceptible women.
Detailed description
This is a research study about the number and types of bacteria that cause urinary tract infections (E. coli strains) that are present in the intestine. The bacteria will be collected and analyzed before and after eating either sweetened, dried cranberries or strawberry fruit pieces. This study will help us learn more about whether or not the components of consumed sweetened, dried cranberries or strawberry fruit pieces reduce the numbers of harmful E. coli bacteria in the vaginal and intestinal tracts, thereby reducing the number of urinary tract infections among women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Active comparator | Other: Sweetened, dried cranberries1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks. |
| No treatment | Other | Other: Observation20 non-UTI susceptible women will be enrolled to collect data on the types of E. coli flora present in non-UTI women. |
| Part 2A | Active comparator | Other: Sweetened, dried cranberries1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for three separate, two-week periods. Each two week period will be separated by a two-week interval. |
| Part 2B | Placebo comparator | Other: Strawberry Fruit Pieces1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for three separate, two-week periods. Each two week period will be separated by a two-week interval. |
| Part 3A | Active comparator | Other: Sweetened, dried cranberries1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period. |
| Part 3B | Placebo comparator | Other: Strawberry Fruit Pieces1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women, ages 18-65
- History of recurrent urinary tract infections defined as three in the past year, or two in the last six months
- Subjects must be willing to follow the study protocol that includes consuming the mandatory daily dose of cranberries or strawberry fruit pieces and traveling to the UWHC Urology clinic for scheduled rectal and vaginal swab procedures.
- The non-UTI-susceptible group will include women ages 18-65 with no history of recurrent UTI's as defined above.
Key exclusion criteria (8 listed)
- Are pregnant
- Have an immune compromising disease
- Have diabetes
- Have kidney stones
- Have chronic bowel inflammatory disease
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 |
|---|---|---|
| Sweetened, dried cranberriesWomen in Arm 1 will consume one serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks. | Other | Part 1, Part 2A, Part 3A |
| Strawberry Fruit Pieces1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for three separate, two-week periods. Each two week period will be separated by a two-week interval. | Other | Part 2B, Part 3B |
| Sweetened, dried cranberries1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for three separate, two-week periods. Each two week period will be separated by a two-week interval. | Other | Part 1, Part 2A, Part 3A |
| Sweetened, dried cranberries1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period. | Other | Part 1, Part 2A, Part 3A |
| Strawberry Fruit Pieces1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period. | Other | Part 2B, Part 3B |
| ObservationSubjects in the non-UTI susceptible group will have one visit where one vaginal and one rectal swab will be collected. | Other | No treatment |
Primary outcome
Pre-treatment heterogeneity or prevalence
Time frame: Day 1 - prior to start of study treatment
1) Prevalence or heterogeneity of E. coli strains in UTI susceptible women pre-treatment
Post-treatment heterogeneity
Time frame: 2 weeks, 1 month, or 3 months
2) a change in the heterogeneity of strains post treatment
Patient acceptance of study regimen
Time frame: 2 weeks, 1 month, or 3 months
3) patient acceptance of the study regimen
Maintenance of heterogeneity in the intestinal flora
Time frame: Approximately 3 months
To determine whether a shift towards strain heterogeneity in the intestinal flora can be maintained over a three month period.
Measure Effects of sweetened, dried cranberries on E. coli clonotypes over three two-week exposures
Time frame: Approximately 3 months
Measure effects of sweetened, dried cranberries on E. coli clonotypes over three two-week exposures
Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure
Time frame: 2 weeks, 1 month, or 3 months
Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure
Measure the UTI recurrence
Time frame: 2 weeks, 1 month, or 3 months
Measure the UTI recurrence after 6 months from the beginning of the study.
Comparison of sweetened dried cranberries to a placebo group
Time frame: 2 weeks, 1 month, or 3 months
Comparison of sweetened dried cranberries to a placebo group (strawberry fruit pieces)
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 29 Jan 2016.
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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.
Walter Hopkins, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sweetened, dried cranberries, Strawberry Fruit Pieces and Observation in people with Urinary Tract Infection, run by University of Wisconsin, Madison 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 4 inclusion and 8 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 29 Jan 2016. 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. Some participants in this study may receive a placebo. 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?
Pre-treatment heterogeneity or prevalence (time frame: Day 1 - prior to start of study treatment). The study lists 8 primary outcomes in all. 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 29 Jan 2016.