Healthy Clinical Trial
— ProFUMOfficial title:
Probiotics and the Female Urinary Microbiome ProFUM Trial (Probiotics Effect on the Female Urinary Microbiome)
NCT number | NCT03250208 |
Other study ID # | 209830 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2017 |
Est. completion date | July 31, 2018 |
Verified date | January 2019 |
Source | Loyola University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | July 31, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Loyola University Medical Center | Maywood | Illinois |
Lead Sponsor | Collaborator |
---|---|
Loyola University |
United States,
Beerepoot 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. Review. Dutch. — View Citation
FitzGerald MP, Brubaker L. Colpocleisis and urinary incontinence. Am J Obstet Gynecol. 2003 Nov;189(5):1241-4. — View Citation
Fitzgerald 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. — View Citation
Fok 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. — View Citation
Foxman 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. — View Citation
Hooton TM. Recurrent urinary tract infection in women. Int J Antimicrob Agents. 2001 Apr;17(4):259-68. Review. — View Citation
Raz 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. — View Citation
Urinary Incontinence Treatment Network (UITN). The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology. J Appl Res. 2008;8(1). pii: AlboVol8No1. — View Citation
Wilton 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 95 days | |
Secondary | 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. | 95 days | |
Secondary | 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. | 95 days | |
Secondary | 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. | 95 days |
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