Probiotics Effect on the Female Urinary Microbiome ProFUM Trial (Probiotics Effect on the Female Urinary Microbiome)

NCT03250208 | Completed

• 1 other identifier: 209830
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy

Keywords

Microbiome; Lactobacillus; Probiotic; Fem-Dophilus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Lactobacillus E. coli ratio in the vagina

  95 days

• Change in Lactobacillus E. coli ratio in the urethra

  95 days

• Prevalence of urinary tract infections

  95 days

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Participants randomized to this group will take two placebo capsules daily during days 21-60.

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

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

Participants randomized to the intervention group will receive Women's Fem Dophilus ® by Jarrow Formulas.

Also known as: Fem Dophilus

Intervention group

Placebo OTHER

Participants randomized to the control group will receive a placebo containing no active ingredients

Also known as: Inactive substance

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (9)

• Urinary Incontinence Treatment Network (UITN). The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology. J Appl Res. 2008;8(1):AlboVol8No1.

  PMID: 24772006 BACKGROUND

• FitzGerald 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.

  PMID: 14634547 BACKGROUND

• 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.

  PMID: 18690402 BACKGROUND

• 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.

  PMID: 23219547 BACKGROUND

• 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.

  PMID: 25882919 BACKGROUND

• 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. Dutch.

  PMID: 16566416 BACKGROUND

• 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. doi: 10.2165/00002018-200326080-00005.

  PMID: 12825971 BACKGROUND

• Hooton 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.

  PMID: 11295405 BACKGROUND

• 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. doi: 10.1056/NEJM199309093291102.

  PMID: 8350884 BACKGROUND

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Elizabeth Mueller, MD

  Loyola University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants and research team members are masked in this randomized placebo-controlled trial. The investigational pharmacist is unmasked.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are randomized to receive placebo or a probiotic using a 1:2 allocation, respectively

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: August 15, 2017
• Study Start: September 1, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)