HealthyProFUMNCT03250208
Probiotics Effect on the Female Urinary Microbiome ProFUM Trial (Probiotics Effect on the Female Urinary Microbiome)
A study testing Probiotic in people with Healthy, run by Loyola University at 1 site in United States.
Trial summary
The study will enroll healthy pre-menopausal female volunteers in the community. These subjects will act as their own controls. The subjects will collect voided urine and peri-urethral swab specimens daily for several months. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 31 Jul 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pre-menopausal healthy women in the community (As defined by presence of menses at least once in the last 12 months).
- Age 18 years or older.
- Agreement to collect daily samples (varying combinations of voided, periurethral, and perianal swabs) for 3 months and bring the samples to Loyola University Medical Center
- Agree to record and return a daily lifestyle diary
- Understand and agree to taking daily oral probiotic or placebo while being blinded
- Able to read and speak English
- Able to obtain clean-catch urine
Who cannot join
- Non-English speaking women
- Allergy or contraindication to the probiotic used in this study
- Prior participation in the study
- Currently pregnant or lactating or planning a pregnancy within 6 months of consenting to participate in the study
- Inability to obtain a 'clean catch' urine sample
- Subjects with an indwelling catheter
- Males are excluded from participation
- Women planning time away for more than 7 days following consent to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: Probiotics and the Female Urinary Microbiome ProFUM Trial (Probiotics Effect on the Female Urinary Microbiome)
The study will enroll healthy pre-menopausal female volunteers in the community. These subjects will act as their own controls. The subjects will collect voided urine and peri-urethral swab specimens daily for several months. They will also be asked to collect vaginal and peri-rectal swab specimens at various time points. Subjects will document various lifestyle variables daily. During the middle of the study, subjects will be randomized to probiotic vs placebo. Using bacterial culture and 16S rRNA gene sequencing, the study will measure the bacterial populations of several anatomic sites longitudinally: voided urine, peri-urethra, vagina, and peri-rectal. The study hypothesizes that oral probiotic usage will alter the bacterial populations and ratio of Lactobacillus to E. coli within each of these sites. Additionally, the study hypothesizes that the changes within each site will occur first in the rectum (i.e. GI tract), followed by the vagina, and then the urethra and bladder.
Using the prospective design of daily sampling and lifestyle variable documentation, the study may be able to identify possible influences on microbiome stability within the sampled sites. The lifestyle variables recorded include: diet, medication usage, menstruation, sexual activity, and alcohol consumption.
This pilot study will establish the variance of the outcome variables among healthy women and confirm the emergence of the probiotic with the recommended dose. With this information, future researchers will be able to calculate the power needed for a larger randomized trial. This trial would also randomize patients who may be at risk for a UTI to receive a probiotic vs placebo. The primary outcome measurement will be the change in the ratio of Lactobacillus to E. coli. As a secondary aim, the study will evaluate the incidence of UTI in the patients.
Read the detailed description
In this study, the primary aim is to identify the change in the Lactobacillus E. coli ratio within the lower urinary tract, the vagina, and the peri-rectal area in response to an oral probiotic as well as to evaluate the stability of these changes following cessation of an oral probiotic. Voided urine and peri-urethral, vaginal, and peri-rectal swab samples will be analyzed for their Lactobacillus E. coli ratio using bacterial culture as well as 16S ribosomal RNA gene sequencing. The study will compare the ratios present before, during, and after oral probiotic usage. The study will also compare the change in ratios between subjects taking the oral probiotic and those taking an oral placebo.
A secondary aim is to identify the normal daily changes (i.e. stability) in the bacterial populations within the voided urine, including whether host intrinsic (e.g. diet, hygiene, and sexual activity) and extrinsic (e.g. menstruation) factors affect the stability of bacterial populations. The bacterial populations defining the voided urine samples will be correlated to various daily subject-reported lifestyle variables. These include diet, hygiene, sexual activity, medication usage, alcohol usage, menstruation, and urinary-related symptoms. These lifestyle variables will be recorded each day for the entire duration of the study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called Fem Dophilus
Participants randomized to the intervention group will receive Women's Fem Dophilus ® by Jarrow Formulas.
PlaceboOther
Also called Inactive substance
Participants randomized to the control group will receive a placebo containing no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Participants randomized to this group will take two placebo capsules daily during days 21-60. Receives: Other: Placebo |
| Intervention group | Experimental | The intervention in this study is a probiotic. Participants randomized to this group will take two capsules of a probiotic daily during days 21-60 Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lactobacillus E. coli ratio in the rectum
We will measure participants' rectal Lactobacillus E. coli ratio at baseline and after treatment. The change in this ratio will be recorded for each participant and compared between the placebo and intervention groups.
Measured: 95 days
Secondary outcomes (3)
Change in Lactobacillus E. coli ratio in the vagina
We will measure participants' vaginal Lactobacillus E. coli ratio at baseline and after treatment. The change in this ratio will be recorded for each participant and compared between the placebo and intervention groups.
Measured: 95 days
Change in Lactobacillus E. coli ratio in the urethra
We will measure participants' urethral Lactobacillus E. coli ratio at baseline and after treatment. The change in this ratio will be recorded for each participant and compared between the placebo and intervention groups.
Measured: 95 days
Prevalence of urinary tract infections
At the final study visit, we will record whether each participant experienced or did not experience a urinary tract infection (UTI). The odds of a UTI among those in the intervention cohort will be compared to the odds of a UTI in the placebo cohort.
Measured: 95 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Sep 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Participants are randomized to receive placebo or a probiotic using a 1:2 allocation, respectively
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Mueller, Loyola University
- Investigators
- Elizabeth Mueller, MD, Principal investigator, Loyola University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250208
- Sponsor's protocol ID
- 209830
- Acronym
- ProFUM
- Status last verified
- Jan 2019
- First submitted
- 19 Jul 2017
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Publications
Urinary Incontinence Treatment Network (UITN). The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology. J Appl Res. 2008;8(1):AlboVol8No1.
PubMed 24772006FitzGerald MP, Brubaker L. Colpocleisis and urinary incontinence. Am J Obstet Gynecol. 2003 Nov;189(5):1241-4. doi: 10.1067/s0002-9378(03)00642-2.
PubMed 14634547Fitzgerald MP, Richter HE, Bradley CS, Ye W, Visco AC, Cundiff GW, Zyczynski HM, Fine P, Weber AM; Pelvic Floor Disorders Network. Pelvic support, pelvic symptoms, and patient satisfaction after colpocleisis. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Dec;19(12):1603-9. doi: 10.1007/s00192-008-0696-6. Epub 2008 Aug 9.
PubMed 18690402Fok CS, McKinley K, Mueller ER, Kenton K, Schreckenberger P, Wolfe A, Brubaker L. Day of surgery urine cultures identify urogynecologic patients at increased risk for postoperative urinary tract infection. J Urol. 2013 May;189(5):1721-4. doi: 10.1016/j.juro.2012.11.167. Epub 2012 Dec 3.
PubMed 23219547Foxman B, Cronenwett AE, Spino C, Berger MB, Morgan DM. Cranberry juice capsules and urinary tract infection after surgery: results of a randomized trial. Am J Obstet Gynecol. 2015 Aug;213(2):194.e1-8. doi: 10.1016/j.ajog.2015.04.003. Epub 2015 Apr 13.
PubMed 25882919Beerepoot MA, ter Riet G, Verbon A, Nys S, de Reijke TM, Geerlings SE. [Non-antibiotic prophylaxis for recurrent urinary-tract infections]. Ned Tijdschr Geneeskd. 2006 Mar 11;150(10):541-4. Dutch.
PubMed 16566416Wilton L, Kollarova M, Heeley E, Shakir S. Relative risk of vaginal candidiasis after use of antibiotics compared with antidepressants in women: postmarketing surveillance data in England. Drug Saf. 2003;26(8):589-97. doi: 10.2165/00002018-200326080-00005.
PubMed 12825971Hooton TM. Recurrent urinary tract infection in women. Int J Antimicrob Agents. 2001 Apr;17(4):259-68. doi: 10.1016/s0924-8579(00)00350-2.
PubMed 11295405Raz R, Stamm WE. A controlled trial of intravaginal estriol in postmenopausal women with recurrent urinary tract infections. N Engl J Med. 1993 Sep 9;329(11):753-6. doi: 10.1056/NEJM199309093291102.
PubMed 8350884
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics and the Female Urinary Microbiome ProFUM Trial (Probiotics Effect on the Female Urinary Microbiome)
- ClinicalTrials.gov ID
- NCT03250208
- Acronym / sponsor ID
- ProFUM / 209830
- Conditions
- Healthy
- Keywords
- Microbiome, Lactobacillus, Probiotic, Fem-Dophilus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 15 Aug 2017 (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 study will enroll healthy pre-menopausal female volunteers in the community. These subjects will act as their own controls. The subjects will collect voided urine and peri-urethral swab specimens daily for several months. They will also be asked to collect vaginal and peri-rectal swab specimens at various time points. Subjects will document various lifestyle variables daily. During the middle of the study, subjects will be randomized to probiotic vs placebo. Using bacterial culture and 16S rRNA gene sequencing, the study will measure the bacterial populations of several anatomic sites longitudinally: voided urine, peri-urethra, vagina, and peri-rectal. The study hypothesizes that oral probiotic usage will alter the bacterial populations and ratio of Lactobacillus to E. coli within each of these sites. Additionally, the study hypothesizes that the changes within each site will occur first in the rectum (i.e. GI tract), followed by the vagina, and then the urethra and bladder.
Using the prospective design of daily sampling and lifestyle variable documentation, the study may be able to identify possible influences on microbiome stability within the sampled sites. The lifestyle variables recorded include: diet, medication usage, menstruation, sexual activity, and alcohol consumption.
This pilot study will establish the variance of the outcome variables among healthy women and confirm the emergence of the probiotic with the recommended dose. With this information, future researchers will be able to calculate the power needed for a larger randomized trial. This trial would also randomize patients who may be at risk for a UTI to receive a probiotic vs placebo. The primary outcome measurement will be the change in the ratio of Lactobacillus to E. coli. As a secondary aim, the study will evaluate the incidence of UTI in the patients.
Detailed description
In this study, the primary aim is to identify the change in the Lactobacillus E. coli ratio within the lower urinary tract, the vagina, and the peri-rectal area in response to an oral probiotic as well as to evaluate the stability of these changes following cessation of an oral probiotic. Voided urine and peri-urethral, vaginal, and peri-rectal swab samples will be analyzed for their Lactobacillus E. coli ratio using bacterial culture as well as 16S ribosomal RNA gene sequencing. The study will compare the ratios present before, during, and after oral probiotic usage. The study will also compare the change in ratios between subjects taking the oral probiotic and those taking an oral placebo.
A secondary aim is to identify the normal daily changes (i.e. stability) in the bacterial populations within the voided urine, including whether host intrinsic (e.g. diet, hygiene, and sexual activity) and extrinsic (e.g. menstruation) factors affect the stability of bacterial populations. The bacterial populations defining the voided urine samples will be correlated to various daily subject-reported lifestyle variables. These include diet, hygiene, sexual activity, medication usage, alcohol usage, menstruation, and urinary-related symptoms. These lifestyle variables will be recorded each day for the entire duration of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized to receive placebo or a probiotic using a 1:2 allocation, respectively
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: PlaceboParticipants randomized to this group will take two placebo capsules daily during days 21-60. |
| Intervention group | Experimental | Dietary Supplement: ProbioticThe intervention in this study is a probiotic. Participants randomized to this group will take two capsules of a probiotic daily during days 21-60 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pre-menopausal healthy women in the community (As defined by presence of menses at least once in the last 12 months).
- Age 18 years or older.
- Agreement to collect daily samples (varying combinations of voided, periurethral, and perianal swabs) for 3 months and bring the samples to Loyola University Medical Center
- Agree to record and return a daily lifestyle diary
- Understand and agree to taking daily oral probiotic or placebo while being blinded
Key exclusion criteria (8 listed)
- Non-English speaking women
- Allergy or contraindication to the probiotic used in this study
- Prior participation in the study
- Currently pregnant or lactating or planning a pregnancy within 6 months of consenting to participate in the study
- Inability to obtain a 'clean catch' urine sample
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 |
|---|---|---|
| ProbioticAlso: Fem DophilusParticipants randomized to the intervention group will receive Women's Fem Dophilus ® by Jarrow Formulas. | Dietary supplement | Intervention group |
| PlaceboAlso: Inactive substanceParticipants randomized to the control group will receive a placebo containing no active ingredients | Other | Control Group |
Primary outcome
Change in Lactobacillus E. coli ratio in the rectum
Time frame: 95 days
We will measure participants' rectal Lactobacillus E. coli ratio at baseline and after treatment. The change in this ratio will be recorded for each participant and compared between the placebo and intervention groups.
3 secondary outcomes
Change in Lactobacillus E. coli ratio in the vagina
Time frame: 95 days
Change in Lactobacillus E. coli ratio in the urethra
Time frame: 95 days
Prevalence of urinary tract infections
Time frame: 95 days
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 1 Feb 2019.
- Background: PubMed 24772006Urinary Incontinence Treatment Network (UITN). The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology. J Appl Res. 2008;8(1):AlboVol8No1.
- Background: PubMed 14634547FitzGerald MP, Brubaker L. Colpocleisis and urinary incontinence. Am J Obstet Gynecol. 2003 Nov;189(5):1241-4. doi: 10.1067/s0002-9378(03)00642-2.
- Background: PubMed 18690402Fitzgerald MP, Richter HE, Bradley CS, Ye W, Visco AC, Cundiff GW, Zyczynski HM, Fine P, Weber AM; Pelvic Floor Disorders Network. Pelvic support, pelvic symptoms, and patient satisfaction after colpocleisis. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Dec;19(12):1603-9. doi: 10.1007/s00192-008-0696-6. Epub 2008 Aug 9.
- Background: PubMed 23219547Fok CS, McKinley K, Mueller ER, Kenton K, Schreckenberger P, Wolfe A, Brubaker L. Day of surgery urine cultures identify urogynecologic patients at increased risk for postoperative urinary tract infection. J Urol. 2013 May;189(5):1721-4. doi: 10.1016/j.juro.2012.11.167. Epub 2012 Dec 3.
- Background: PubMed 25882919Foxman B, Cronenwett AE, Spino C, Berger MB, Morgan DM. Cranberry juice capsules and urinary tract infection after surgery: results of a randomized trial. Am J Obstet Gynecol. 2015 Aug;213(2):194.e1-8. doi: 10.1016/j.ajog.2015.04.003. Epub 2015 Apr 13.
- Background: PubMed 16566416Beerepoot MA, ter Riet G, Verbon A, Nys S, de Reijke TM, Geerlings SE. [Non-antibiotic prophylaxis for recurrent urinary-tract infections]. Ned Tijdschr Geneeskd. 2006 Mar 11;150(10):541-4. Dutch.
- Background: PubMed 12825971Wilton L, Kollarova M, Heeley E, Shakir S. Relative risk of vaginal candidiasis after use of antibiotics compared with antidepressants in women: postmarketing surveillance data in England. Drug Saf. 2003;26(8):589-97. doi: 10.2165/00002018-200326080-00005.
- Background: PubMed 11295405Hooton TM. Recurrent urinary tract infection in women. Int J Antimicrob Agents. 2001 Apr;17(4):259-68. doi: 10.1016/s0924-8579(00)00350-2.
- Background: PubMed 8350884Raz R, Stamm WE. A controlled trial of intravaginal estriol in postmenopausal women with recurrent urinary tract infections. N Engl J Med. 1993 Sep 9;329(11):753-6. doi: 10.1056/NEJM199309093291102.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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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.
Elizabeth Mueller, MD principal investigator
Loyola University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Healthy, run by Loyola 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 7 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 1 Feb 2019. 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?
Change in Lactobacillus E. coli ratio in the rectum (time frame: 95 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03250208, which also lists 9 linked publications.
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 1 Feb 2019.