NCT03042923|Completed
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Sponsor study identifier
observational
46
1 country
2
Study Start
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2019
Actual (reported)Study Completion
June 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
February 1, 2017
Actual (reported)February 3, 2017
Actual (reported)June 2019
Actual (reported)June 2019
Actual (reported)lactulose:mannitol (L:M) oral challenge
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.
6 hrs
Surgical Findings
24 hrs
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
Ten healthy female patients, without pelvic pain or history of autoimmune disease, will be asked to participate as controls.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
Women's Surgery Center
Chattanooga, Tennessee, 37421, United States
WITEBSKY E, ROSE NR, TERPLAN K, PAINE JR, EGAN RW. Chronic thyroiditis and autoimmunization. J Am Med Assoc. 1957 Jul 27;164(13):1439-47. doi: 10.1001/jama.1957.02980130015004. No abstract available.
Eisenberg VH, Zolti M, Soriano D. Is there an association between autoimmunity and endometriosis? Autoimmun Rev. 2012 Sep;11(11):806-14. doi: 10.1016/j.autrev.2012.01.005. Epub 2012 Feb 4.
Fasano A. Physiological, pathological, and therapeutic implications of zonulin-mediated intestinal barrier modulation: living life on the edge of the wall. Am J Pathol. 2008 Nov;173(5):1243-52. doi: 10.2353/ajpath.2008.080192. Epub 2008 Oct 2.
Shanti Mohling, MD
UT College of Medicine
Patti Bush, EdD
UT College of Medicine
Garrett Lam, MD
UT College of Medicine
Steve Radtke, MD
UT College of Medicine
46 participants (actual enrollment reported by the registry).
First Submitted
February 1, 2017
First Posted
February 3, 2017
Study Start
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Fasano A. Zonulin, regulation of tight junctions, and autoimmune diseases. Ann N Y Acad Sci. 2012 Jul;1258(1):25-33. doi: 10.1111/j.1749-6632.2012.06538.x.
Watts T, Berti I, Sapone A, Gerarduzzi T, Not T, Zielke R, Fasano A. Role of the intestinal tight junction modulator zonulin in the pathogenesis of type I diabetes in BB diabetic-prone rats. Proc Natl Acad Sci U S A. 2005 Feb 22;102(8):2916-21. doi: 10.1073/pnas.0500178102. Epub 2005 Feb 14.
Bjarnason I, MacPherson A, Hollander D. Intestinal permeability: an overview. Gastroenterology. 1995 May;108(5):1566-81. doi: 10.1016/0016-5085(95)90708-4.
Primary Completion
June 2019
Actual (reported)Study Completion
June 2019
Actual (reported)Last Updated
April 28, 2020
Record last verified: 2020-04
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