Intestinal Permeability and Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

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.
    

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.
    

Intervention name(s): lactulose:mannitol (L:M) oral challenge
Intervention type(s): Drug
Intervention MeSH terms: Mannitol; Lactulose
Observational model: Case-Control
Time perspective: Prospective
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.
      
Keywords: Intestinal permeability