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Microbiomes of Interstitial Cystitis

This study is currently recruiting participants.
Verified February 2014 by Northwestern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Klumpp, Northwestern University
ClinicalTrials.gov Identifier:
NCT01738464
First received: November 28, 2012
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

Interstitial cystitis/painful bladder syndrome (IC/PBS) is characterized by chronic pelvic pain and voiding dysfunction. IC remains an enigma within urology, with no known etiology or widely effective therapies. However, some IC patients suffer bowel co-morbidities, and it is well established that the GI tract can influence bladder function and sensation via pelvic organ crosstalk.

Like other body sites, the gut harbors a rich microflora. Studies characterizing microbial diversity and relative abundance at a particular body site, the "microbiome," reveal that microbiomes play critical roles in normal cellular and organ function, and thus this importance is emphasized with the Human Microbiome Project (HMP), an NIH Common Fund initiative. Microbiomes are also dynamic and subject to skewing, and these changes are increasingly associated with diseases including Crohn's disease, ulcerative colitis, and obesity. Antibiotic therapies alter microbiomes, often causing temporary dysfunction and sometimes resulting in diseases such as colitis. Since IC patients often have a history of urinary tract infection (UTI), they typically receive multiple courses of antibiotics. This therapeutic history of IC patients may have adverse consequences for two reasons. First, potential skewing of the gut microbiome may alter normal sensory and functional homeostatic mechanisms, contributing to pain and voiding dysfunction.

Second, an altered gut microbiome may foster uropathogen reservoir expansion, and our preliminary data demonstrate urinary E. coli isolates can induce chronic pelvic pain persisting long after microbial clearance. Together these lines of reasoning raise the provocative possibility that microbiomes contribute to IC directly by supplying uropathogens or indirectly through organ crosstalk dysfunction. Therefore, is an altered gastrointestinal and/or reproductive tract microbiome associated with IC? Our team marries core NIH and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) missions, digestive diseases and kidney/urologic, to address this novel question with synergistic expertise in clinical diagnosis of IC, quantifying GI and reproductive tract microbiomes, and mechanisms of microbe-induced pelvic pain.


Condition
Interstitial Cystitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Microbiomes of Interstitial Cystitis

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Genotype Anaerobic Bacterial populations between Control patients and patients diagnosed with Interstitial Cystitis [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Anaerobic bacteria will be collected from 3 areas of the vagina and a fecal specimen from both Control patients and patients diagnosed with Interstitial Cystitis. Genotyping will be done to differentiate bacterial populations between the Control patients and patients with Interstitial Cystitis.


Biospecimen Retention:   Samples With DNA

Urine specimen, Vaginal Swab specimen, Stool specimen.


Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Interstitial Cystitis patients
Interstitial Cystitis patients will be compared to Healthy patients and also patients suffering form urinary tract infection.
Controls
Both healthy patients and patients suffering for urinary tract infection will be used as controls to compare to patients diagnosed with interstitial cystitis.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic patients Community sample

Criteria

Inclusion Criteria:

  • Female
  • Pre-menopausal
  • Between the ages of 18 and 45
  • Any ethnicity
  • Have provided informed consent
  • Report symptoms of discomfort or pain in the pelvic or abdominal region of moderate severity for at least a three (3) month period within the last six (6) months
  • Are healthy, age matched, controls.

Exclusion Criteria:

  • Evidence of facultative Gram negative or enterococcus with a value of ≥ 100,000 colony forming units (CFU)/milliliter in mid-stream urine (VB2)
  • Secondary chronic pain condition which would prevent a clear interpretation of the study results
  • A history of tuberculous cystitis, bladder cancer, carcinoma in situ, or urethral cancer; history of alcohol abuse, inflammatory bowel disease, pelvic radiation or systemic chemotherapy, intravesical chemotherapy, intravesical Bacillus Calmette-Guerin (BCG), active urethral stricture, ureteral calculi, urethral diverticulum, or neurological disease or disorder affecting the bladder or gut
  • Unlikely to be compliant due to unmanaged medical or psychological conditions, including neurological, psychological or speech/language problems that will interfere or prevent with her understanding of consent
  • Her ability to comply with the protocol or ability to complete the study
  • Pregnant or Syndromes of Chronic Pelvic Pain (SCPP) symptoms are present only during menses
  • And if there was antibiotic use in the last 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738464

Contacts
Contact: Darlene S Marko, RN 312.695.3898 d-marko@northwestern.edu
Contact: David J Klumpp, PhD 312.908.1996 d-klumpp@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: David J Klumpp, PhD Northwestern University
  More Information

No publications provided

Responsible Party: David Klumpp, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01738464     History of Changes
Other Study ID Numbers: STU00055668, 1R24DK094575-01
Study First Received: November 28, 2012
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Pelvic Pain
Interstitial Cystitis
Microbiome

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014