EndometriosisNCT03042923
Intestinal Permeability and Endometriosis
An observational study of Endometriosis, run by University of Tennessee at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- lactulose:mannitol (L:M) oral challenge
- Type of treatment
- Pill or oral medicine
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2016to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Female patients with documented history of pelvic pain for the study arm.
- Healthy female controls without history consistent with autoimmune disease or pelvic pain
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Erlanger Medical Center
Chattanooga, Tennessee, 37403
Women's Surgery Center
Chattanooga, Tennessee, 37421
About this study
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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- lactulose:mannitol (L:M) oral challenge
- Keywords
- Intestinal permeability
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactulose:mannitol (L:M) oral challengeDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: lactulose:mannitol (L:M) oral challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hrs
Secondary outcomes (1)
Surgical Findings
Pathology reported-- endometriosis or no endometriosis
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study startApr 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shanti Mohling, MD, Principal investigator, UT College of MedicinePatti Bush, EdD, Study director, UT College of MedicineGarrett Lam, MD, Study chair, UT College of MedicineSteve Radtke, MD, Principal investigator, UT College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042923
- Sponsor's protocol ID
- 16-029
- Status last verified
- Apr 2020
- First submitted
- 1 Feb 2017
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 13448890Eisenberg 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.
PubMed 22330229Fasano 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.
PubMed 18832585Fasano 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.
PubMed 22731712Watts 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.
PubMed 15710870Bjarnason I, MacPherson A, Hollander D. Intestinal permeability: an overview. Gastroenterology. 1995 May;108(5):1566-81. doi: 10.1016/0016-5085(95)90708-4.
PubMed 7729650
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Permeability and Endometriosis
- ClinicalTrials.gov ID
- NCT03042923
- Acronym / sponsor ID
- 16-029
- Conditions
- Endometriosis
- Keywords
- Intestinal permeability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: lactulose:mannitol (L:M) oral challengeTwenty 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 |
| Control | – | Drug: lactulose:mannitol (L:M) oral challengeTen healthy female patients, without pelvic pain or history of autoimmune disease, will be asked to participate as controls. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Female patients with documented history of pelvic pain for the study arm.
- Healthy female controls without history consistent with autoimmune disease or pelvic pain
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lactulose:mannitol (L:M) oral challenge | Drug | Control, Treatment |
Primary outcome
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.
1 secondary outcome
Surgical Findings
Time frame: 24 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Background: PubMed 13448890WITEBSKY 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.
- Background: PubMed 22330229Eisenberg 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.
- Background: PubMed 18832585Fasano 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.
- Background: PubMed 22731712Fasano 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.
- Background: PubMed 15710870Watts 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.
- Background: PubMed 7729650Bjarnason I, MacPherson A, Hollander D. Intestinal permeability: an overview. Gastroenterology. 1995 May;108(5):1566-81. doi: 10.1016/0016-5085(95)90708-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanti Mohling, MD principal investigator
UT College of Medicine
Patti Bush, EdD study director
UT College of Medicine
Garrett Lam, MD study chair
UT College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by University of Tennessee at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lactulose:mannitol (L:M) oral challenge (time frame: 6 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03042923, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.