Microbiomes of Pelvic Pain - ClinicalTrials.gov


https://clinicaltrials.gov/ct2/show/study/NCT01738464

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Microbiomes of Pelvic Pain
This study is currently recruiting participants. (see Contacts and Locations) Verified April 2016 by Northwestern University
Sponsor:
Northwestern University
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Information provided by (Responsible Party):
David Klumpp, Northwestern University
ClinicalTrials.gov Identifier:
NCT01738464
First received: November 28, 2012
Last updated: April 6, 2016
Last verified: April 2016
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record


Purpose
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.

Condition
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:

MedlinePlus related topics: Interstitial Cystitis Pelvic Pain Urine and Urination
U.S. FDA Resources

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)
Groups/Cohorts
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.
Controls
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.
Eligibility

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
Criteria
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:

For IC/CPPS/LUTS/OAB

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 ClinicalTrials.gov identifier: NCT01738464

Contacts
Contact: David J Klumpp, PhD 312.908.1996 d-klumpp@northwestern.edu
Contact: Anthony J Schaeffer, MD 312.908.9844 ajschaeffer@northwestern.edu

Locations
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) Investigators
Principal Investigator: David J Klumpp, PhD Northwestern University
More Information

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: April 6, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Pelvic Pain
Interstitial Cystitis
Microbiome
Prostatitis
Chronic
Depression

Additional relevant MeSH terms:
Depression
Urinary Bladder, Overactive
Depressive Disorder, Major
Lower Urinary Tract Symptoms
Cystitis, Interstitial
Pelvic Pain
Cystitis
Prostatitis
Behavioral Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations
Prostatic Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on December 15, 2016

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