Microbiomes of Pelvic Pain

NCT01738464 | Completed

• 2 other identifiers: STU000556681R01DK103769-01A1
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Pelvic Pain; Interstitial Cystitis; Microbiome; Prostatitis; Chronic; Depression

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  1 day

• Separate serum from blood specimen given by Control patients and patients diagnosed with Interstitial Cystitis or Chronic Prostatitis/Chronic Pelvic Pain Syndrome, Lower Urinary Tract Symptoms, Overactive Bladder, and Major Depression

  If you are a local patient: Blood will be collected and serum will be separated and analyzed for HPA markers associated with the anaerobic organisms found in the microbiome.

  3 days

• Collect urine specimen from Control patients and patients diagnosed with Interstitial Cystitis or Chronic Prostatitis/Chronic Pelvic Pain Syndrome, Lower Urinary Tract Symptoms, Overactive Bladder, and Major Depression

  If you are a local patient: Urine will be analyzed for the presence of bacteria, and HPA markers associated with the organisms found in the microbiome.

  3 days

Study Arms (3)

Pelvic Pain

Interstitial Cystitis or Chronic Prostatitis/Chronic Pelvic Pain Syndrome, Lower Urinary Tract Symptoms, and Overactive Bladder patients will be compared to Healthy and Depressed 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, Overactive Bladder, and Depressed patients.

Major Depression

Major Depression patients will be compared to Controls and Pelvic Pain cohorts.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic patients Community sample

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool specimen, Blood/Serum specimen, Urine specimen

MeSH Terms

Conditions

Cystitis, Interstitial; Lower Urinary Tract Symptoms; Urinary Bladder, Overactive; Depressive Disorder, Major; Pelvic Pain; Prostatitis; Bronchiolitis Obliterans Syndrome; Depression

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders; Pain; Neurologic Manifestations; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Behavioral Symptoms; Behavior

Study Officials

• David J Klumpp, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: November 30, 2012
• Study Start: June 1, 2012
• Primary Completion: July 7, 2023
• Study Completion: July 8, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

US (1)