Intestinal Permeability and Endometriosis

NCT03042923 | Completed

• 1 other identifier: 16-029
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Endometriosis

Keywords

Intestinal permeability

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Surgical Findings

  24 hrs

Study Arms (2)

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

Interventions

lactulose:mannitol (L:M) oral challenge DRUG

Control; Treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (2)

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

Women's Surgery Center

Chattanooga, Tennessee, 37421, United States

Location

Related Publications (6)

• 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.

  PMID: 13448890 BACKGROUND

• 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.

  PMID: 22330229 BACKGROUND

• 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.

  PMID: 18832585 BACKGROUND

• 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.

  PMID: 22731712 BACKGROUND

• 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.

  PMID: 15710870 BACKGROUND

• 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.

  PMID: 7729650 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Shanti Mohling, MD

  UT College of Medicine

  PRINCIPAL INVESTIGATOR

• Patti Bush, EdD

  UT College of Medicine

  STUDY DIRECTOR

• Garrett Lam, MD

  UT College of Medicine

  STUDY CHAIR

• Steve Radtke, MD

  UT College of Medicine

  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: February 1, 2017
• First Posted: February 3, 2017
• Study Start: April 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)