Intestinal Permeability and Endometriosis

Conditions:Women's Studies, Endometriosis
Therapuetic Areas:Other, Reproductive
Age Range:18 - 40
Start Date:April 2016
End Date:December 2018
Contact:Shanti I Mohling

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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.

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.

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

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.
We found this trial at
Chattanooga, Tennessee 37403
Principal Investigator: Shanti Mohling, MD
Phone: 575-770-2841
Chattanooga, TN
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Chattanooga, Tennessee 37421
Phone: 423-899-6511
Chattanooga, TN
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