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Intestinal Permeability and Endometriosis

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ClinicalTrials.gov Identifier: NCT03042923
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
University of Tennessee

Brief Summary:
The objective of this project will be to determine whether patients with a surgical diagnosis of endometriosis have impaired intestinal permeability as compared with healthy controls. This would suggest the presence of an environmentally triggered and intestinally mediated association in the etiology of endometriosis. This would be a proof of concept trial to establish whether there is in fact a relationship worthy of future research.

Condition or disease Intervention/treatment
Endometriosis Drug: lactulose:mannitol (L:M) oral challenge

Detailed Description:

Twenty patients with a clinical diagnosis of endometriosis who are scheduled for surgical evaluation will be eligible for the study arm of the research. Ten women without history of autoimmune disease or pelvic pain will serve as controls.

Study subjects will undergo testing for intestinal permeability a week or more before their scheduled surgery. Both controls and pain patients will be tested for permeability using a lactulose:mannitol (L:M) oral challenge. Each subject will ingest an oral preparation of Lactulose 5 gm, Mannitol 1gm and water. This preparation is available as a test kit through Genova Diagnostics labs. Erlanger Hospital lab does not have a test for measuring urinary excretion of L:M, or other method of assessing intestinal permeability.

Urine is collected over six hours and is then measured for ratio of L:M. An L:M ratio >0.10 is consistent with increased intestinal permeability. Normally the gut does not absorb lactulose unless permeability is present. NSAIDS and alcohol increase intestinal permeability; therefore subjects will be asked to avoid the use of NSAIDS and alcoholic beverages for a week prior to the test.

Following the L:M testing, the patients who have been enrolled will undergo surgery as planned. The surgeons should be blinded to the results of the L:M testing until after the surgery. It is assumed that some of the patients will have surgical evidence of endometriosis and some will not. The ultimate categories for analysis will be 1) Pain with biopsy proven endometriosis, and surgical staging of disease, 2) Pain without surgical evidence of endometriosis, 3) Control patients with no history of chronic pain, alcoholism, celiac disease or other autoimmune disease. As a secondary element of this study, correlation to the presence of interstitial cystitis (IC) will also be assessed as all patients in our practice who undergo surgical evaluation for chronic pain simultaneously are evaluated for IC by cystoscopy with hydrodistention.

Data that the investigators will gather includes: demographic, pelvic pain parameters, information on use of tobacco and alcohol, medical history to exclude autoimmune disease patients and patients with diabetes, intestinal permeability test results and date of test, surgical findings, American Society of Reproductive Medicine, ASRM, Endometriosis staging when applicable, presence of extrapelvic endometriosis, pathology results and presence or absence of interstitial cystitis.

Because this is an unexplored area of research, preliminary data to demonstrate potential efficacy before embarking on a prospective trial is essential.

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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Intestinal Permeability and Endometriosis
Study Start Date : April 2016
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Group/Cohort Intervention/treatment
Treatment
Twenty patients, known to us through care at Women's Surgery Center and the private practice of Dr. R. Scott Furr, will be invited to enroll based on a history of pelvic pain and a plan for surgical evaluation and intervention
Drug: lactulose:mannitol (L:M) oral challenge
Control
Ten healthy female patients, without pelvic pain or history of autoimmune disease, will be asked to participate as controls.
Drug: lactulose:mannitol (L:M) oral challenge



Primary Outcome Measures :
  1. lactulose:mannitol (L:M) oral challenge [ Time Frame: 6 hrs ]
    Urine is collected over six hours and is then measured for ratio of L:M. An L:M ratio >0.10 is consistent with increased intestinal permeability. Normally the gut does not absorb lactulose unless permeability is present.


Secondary Outcome Measures :
  1. Surgical Findings [ Time Frame: 24 hrs ]
    Pathology reported-- endometriosis or no endometriosis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited through care at Women's Surgery Center and the private practice of Dr. R. Scott Furr and through Erlanger Women's Specialty Services and the practice of Dr. Shanti Mohling. Participants will be invited to enroll based on a history of pelvic pain and a plan for surgical evaluation and intervention. Ten healthy female women, without pelvic pain or history of autoimmune disease, will be asked to participate as controls.
Criteria

Inclusion Criteria:

  • Female patients with documented history of pelvic pain for the study arm.
  • Healthy female controls without history consistent with autoimmune disease or pelvic pain

Exclusion Criteria:

  • Co-morbid autoimmune disease such as Celiac disease, lupus, ankylosing spondylitis, alcoholism and diabetes which have been shown to exhibit elevated levels of Zonulin and therefore impaired intestinal permeability. Drinking alcohol and taking NSAIDS elevate intestinal permeability and would affect data.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042923


Locations
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United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
Women's Surgery Center
Chattanooga, Tennessee, United States, 37421
Sponsors and Collaborators
University of Tennessee
Investigators
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Principal Investigator: Shanti Mohling, MD UT College of Medicine
Study Director: Patti Bush, EdD UT College of Medicine
Study Chair: Garrett Lam, MD UT College of Medicine
Principal Investigator: Steve Radtke, MD UT College of Medicine
Publications:
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Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT03042923    
Other Study ID Numbers: 16-029
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Tennessee:
Intestinal permeability
Additional relevant MeSH terms:
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Endometriosis
Mannitol
Lactulose
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Gastrointestinal Agents