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Microbiomes of Pelvic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Northwestern University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
David Klumpp, Northwestern University Identifier:
First received: November 28, 2012
Last updated: April 6, 2016
Last verified: April 2016
This research study seeks to provide more insight as to how the microbiome affects or is affected by conditions causing chronic pelvic pain such as Interstitial Cystitis (IC), Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Lower Urinary Tract Symptoms (LUTS), or Overactive bladder (OAB). Depression and many chronic pain disorders are often related and are poorly understood, and treatment is often not helpful. The goal of this study is to explain pelvic pain characteristics and causes by studying microbiomes of healthy people compared to people suffering from IC, CP/CPPS, LUTS, OAB, and Major depression.

Interstitial Cystitis
Chronic Prostatitis
Chronic Pelvic Pain Syndrome
Lower Urinary Tract Symptoms
Overactive Bladder
Major Depression

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Microbiomes of Pelvic Pain

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 or Chronic Prostatitis/Chronic Pelvic Pain Syndrome, Lower Urinary Tract Symptoms, Overactive Bladder, and Major Depression [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Anaerobic bacteria will be collected from a fecal specimen from both Control patients and patients diagnosed with Interstitial Cystitis or Chronic Prostatitis/Chronic Pelvic Pain Syndrome, Lower Urinary Tract Symptoms, Overactive Bladder, and/or Major Depression. Genotyping will be done to differentiate bacterial populations between the Control patients and patients with Interstitial Cystitis or Chronic Prostatitis/Chronic Pelvic Pain Syndrome, Lower Urinary Tract Symptoms, Overactive Bladder, and/or Major Depression.

Biospecimen Retention:   Samples With DNA
Stool specimen

Estimated Enrollment: 300
Study Start Date: June 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Pelvic Pain
Interstitial Cystitis or Chronic Prostatitis/Chronic Pelvic Pain Syndrome, Lower Urinary Tract Symptoms, and Overactive Bladder patients will be compared to Healthy patients.
Healthy patients will be used as controls to compare to patients diagnosed with interstitial cystitis, chronic prostatitis, chronic pelvic pain syndrome, Lower Urinary Tract Symptoms, or Overactive Bladder
Major Depression
Major Depressed patients will be compared to Controls and Pelvic Pain cohorts.

Detailed Description:
Interstitial cystitis/painful bladder syndrome (IC), Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Lower Urinary Tract Infection Symptoms (LUTS), and Overactive bladder (OAB) are characterized by chronic pelvic pain and voiding dysfunction.These conditions remain an enigma within urology, with no known etiology or widely effective therapies. However, some IC/CP/CPPS/LUTS/OAB and depressed patients suffer bowel co-morbidities, and it is well established that the GI tract can influence bladder function, mood, and sensation via pelvic organ crosstalk. Like other body sites, the gut harbors a rich microflora. It is also well established that IC/CP/CPPS/LUTS/OAB patients often suffer from depression. Therefore, in addition to IC/CP/CPPS/LUTS/OAB patients, we seek patients currently suffering from major depression. Our goal is to identify differences in gut microbiota associated with pelvic pain and determine the mechanisms by which gut microbiota influence gut-brain interactions in pelvic pain. 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, obesity, and possibly depression. Antibiotic therapies alter microbiomes, often causing temporary dysfunction and sometimes resulting in diseases such as colitis. Since IC/CP/CPPS/LUTS/OAB patients often have a history of urinary tract infection (UTI), they typically receive multiple courses of antibiotics. This therapeutic history of IC/CP/CPPS/LUTS/OAB 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/CP/CPPS/LUTS/OAB and depression directly by supplying uropathogens or indirectly through organ crosstalk dysfunction. Therefore, is an altered gastrointestinal and/or reproductive tract microbiome associated with these chronic pelvic pain conditions and depression? Our team marries core NIH and NIDDK missions, digestive diseases and kidney/urologic as well psychiatric disciplines, to address this novel question with synergistic expertise in clinical diagnosis of IC/CP/CPPS/LUTS/OAB and depression, quantifying GI tract microbiomes, and neural mechanisms of microbe-induced pelvic pain or depression.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic patients Community sample

Inclusion Criteria:

  • Any sex
  • Between the ages of 18 and 60
  • Any ethnicity
  • Have provided informed consent
  • Physician diagnosis of interstitial cystitis/bladder pain syndrome (IC/BPS), interstitial cystitis/painful bladder syndrome (IC/PBS), chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), Lower Urinary Tract Symptoms, Overactive Bladder, or Major Depression.
  • 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, who have been currently diagnosed with major depression
  • 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 their understanding of consent
  • 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

For Depressed Patients:

  • Participant is in remission or has recovered from major depression, has substance abuse in the past 6 months, has been diagnosed with any bipolar or psychotic disorder, has been diagnosed with any severe cognitive impairment or dementia, history of cancer (with the exception of skin cancer), has current major psychiatric disorder or other psychiatric or medical comorbidities that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, lupus, active heart failure, diabetes, etc., currently has a UTI and/or has had a positive urine culture in the past 6 weeks, and if there was antibiotic use in the last 3 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01738464

Contact: David J Klumpp, PhD 312.908.1996
Contact: Anthony J Schaeffer, MD 312.908.9844

United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: David J Klumpp, PhD Northwestern University
  More Information

Responsible Party: David Klumpp, Associate Professor, Northwestern University Identifier: NCT01738464     History of Changes
Other Study ID Numbers: STU00055668  1R24DK094575-01 
Study First Received: November 28, 2012
Last Updated: April 6, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Pelvic Pain
Interstitial Cystitis

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Depressive Disorder, Major
Lower Urinary Tract Symptoms
Cystitis, Interstitial
Pelvic Pain
Behavioral Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders
Prostatic Diseases
Genital Diseases, Male
Neurologic Manifestations processed this record on October 27, 2016