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Ertan Digestive Disease Center - IBD

Inflammatory Bowel Disease (IBD) Center

The Ertan Digestive Disease Center and the Gastroenterology Center of Excellence at Memorial Hermann-TMC and UT Health provides multidisciplinary specialized care for patients with chronic ulcerative colitis, Crohn’s disease, microscopic colitides and related disorders. The Center's gastroenterologists work closely with designated physician assistants, colorectal surgeons, mental health specialists, pathologists, radiologists, pediatricians, immunologists and nutritionists — all of whom have specific skills and training in the treatment of Inflammatory Bowel Disease.

Successful management of IBD requires early and accurate diagnosis of IBD and implementation of appropriate medical, surgical, and nutritional therapy with a fully integrated program based model aimed at optimizing patient care, postgraduate education and clinical and translational research in IBD.

In addition to routine endoscopic methods, upgraded PillCam small bowel capsule endoscopy, CT/MRI enterography, antegrade and retrograde balloon enteroscopy and other modalities are available to our IBD patients. With the recent advent of balloon-assisted enteroscopy, this has enabled our gastroenterologists to treat complicated strictures endoscopically deep within the small intestine that in the past were only able to be treated surgically.

We also focus on cancer surveillance, women’s health, and the transition of care from pediatric to adult programs. Within the clinic structure at the Center, there are multiple clinics focused specifically on the care of IBD patients.

Research & Clinical Trials

The Ertan Center has access to cutting-edge clinical research focused on new and alternative treatments for IBD conducted through multicenter national trials with well-designed multicenter research protocols.  These protocols incorporate new pharmaceutical agents which are not commercially available and are especially important for the treatment of our patients who have failed other conventional therapies.

Because of the chronic nature of these diseases, our mission is to assist patients with their on-going physical, nutritional, educational, and psychosocial needs. Through collaboration with integrated colorectal surgeons, we are able to treat patients with complicated perirectal disease and stricturing disease, frequently without the need for intestinal resection. Therefore, we will provide individualized comprehensive assessment and management plans utilizing the latest diagnostic procedures and treatment options available.  Our comprehensive database, national trials and outcome analysis will help to maintain our position at the forefront in the management of patients with IBD.

Rifaximin Treatment of Rome II Established Irritable Bowel Syndrome (IBS) A Pilot Study to Evaluate a Maintenance Dosing Regimen (IBS-Rifaximin)
Principal Investigator: Andrew DuPont, M.D., M.S.P.H.

The purpose of this study is to find out if patients who begin to feel better with Rifaximin (antibiotic) after a 10 day treatment continue to feel better for a period of four months or feel worse after switching to placebo (a placebo is an inactive substance that is made to look exactly like the active drug). This study also is looking for a possible relationship between human genetic factors(those you were born with) and occurrence of IBS and the study will examine whether your IBS started with an intestinal infection or not.

A Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects with Irritable Bowel Syndrome with Diarrhea (IBS-D) (RFIB3053)
Principal Investigator: Andrew DuPont, M.D., M.S.P.H.

This study is being conducted to help us learn more about how to help people who have IBS-D.  The sponsor of this study, Salix Pharmaceuticals, Inc., is studying the use of rifaximin (an antibiotic) compared to placebo (a medically inactive substance which has no active ingredients) in the treatment of IBS-D. The purpose of this study is to determine if rifaximin is safe and helpful in treating IBS-D symptoms in patients who previously were helped by rifaximin treatment.

A Phase 3, Randomized, Double-blind,Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI 3001)
Principal Investigators: Atilla Ertan, M.D., FACP, MACG, AGAF and Andrew DuPont, M.D., M.S.P.H.

The purpose of this study is to determine whether or not treatment with ustekinumab improves symptoms of Crohn's disease and also to look for any possible side effects in patients with this disease.  If this study has positive results, it would be used to apply for approval for this drug in Crohn's Disease. Ustekinumab is an experimental drug that is being tested to see if it is useful in treating Crohn's Disease.  This study will compare the benefits and risks of ustekinumab to placebo.

A Phase 3, Randomized, Double-blind, Placebo-controlled,Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease (UNITI 3002)
Principal Investigators: Atilla Ertan, M.D., FACP, MACG, AGAF and Andrew DuPont, M.D., M.S.P.H.

The purpose of this study is to determine whether or not treatment with ustekinumab improves symptoms of Crohn's disease and also to look for any possible side effects in patients with this disease. If this study has positive results, it would be used to apply for approval for this drug in Crohn's Disease. Ustekinumab is an experimental drug that is being tested to see if it is useful in treating Crohn's Disease. This study will compare the benefits and risks of ustekinumab to placebo.

A Phase 3, Randomized, Double-blind,Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease (IMUNITI/3003)
Principal Investigators: Atilla Ertan, M.D., FACP, MACG, AGAF and Andrew DuPont, M.D., M.S.P.H.

The purpose of this study is to determine whether or not treatment with Ustekinumab improves symptoms of Crohn's disease long-term, especially looking to see how the response of the drug can be maintained in those who experienced improvement after the original treatment.

Rifaximin Treatment of Rome II Established Irritable Bowel Syndrome (IBS) A Pilot Study to Evaluate a Maintenance Dosing Regimen (IBS-Rifaximin)
Principal Investigator: Andrew DuPont, M.D., M.S.P.H.

The purpose of this study is to find out if patients who begin to feel better with Rifaximin (antibiotic) after a 10 day treatment continue to feel better for a period of four months or feel worse after switching to placebo (a placebo is an inactive substance that is made to look exactly like the active drug). This study also is looking for a possible relationship between human genetic factors(those you were born with) and occurrence of IBS and the study will examine whether your IBS started with an intestinal infection or not.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASARegimen (Budesonide MMX UC)
Principal Investigators: Atilla Ertan, M.D., FACP, MACG, AGAF and Andrew DuPont, M.D., M.S.P.H.

The purpose of this research study is to evaluate the effectiveness and safety of the budesonide MMX 9mg oral formulation, compared to placebo (an inactive substance), when either is added to an existing 5-ASA regimen. Half the participants will receive the placebo in this study.

A Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects with Irritable Bowel Syndrome with Diarrhea (IBS-D) (RFIB3053)
Principal Investigator: Andrew DuPont, M.D., M.S.P.H.

This study is being conducted to help us learn more about how to help people who have IBS-D.  The sponsor of this study, Salix Pharmaceuticals, Inc., is studying the use of rifaximin (an antibiotic) compared to placebo (a medically inactive substance which has no active ingredients) in the treatment of IBS-D. The purpose of this study is to determine if rifaximin is safe and helpful in treating IBS-D symptoms in patients who previously were helped by rifaximin treatment.

Phase 2 Assessment of the Relationship between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally AdministeredLX1606 in Subjects with Acute, Mild to Moderate Ulcerative Colitis (LX1606.204)
Principal Investigator: Andrew DuPont, M.D., M.S.P.H.

The purpose of this study is to evaluate two dose levels ofLX1606 (500 mg given once a day or 500 mg given three times daily)to determine the following:  Safety and tolerability of LX1606in patients with acute, mild to moderate ulcerative colitis. Effects LX1606 has on patients and the symptoms associated with acute, mild to moderate ulcerative colitis.

Ulcerative Colitis:

  • A Phase III, Double-Blind, Randomized, Placebo-Controlled, Combined Induction and Maintenance Multicenter Study To Evaluate the Safety and Efficacy of GS-5745 [MMP-9, gelatinase inhibitor] SC in Subjects with Moderately to Severely Active CUC, with Gilead Pharm.: Subjects will receive a maximum of 52 wks study agent.
  • A Phase III, Blinded, Placebo-controlled, Multicenter Study of the Efficacy and Safety of  Etrolizumab During Induction and Maintenance in Patients with moderate to severe active CUC who are Refractory to or Intolerant of TNF Inhibitors, with F. Hoffmann-La Roche Ltd.: Patients not achieving clinical response at week 10 may be eligible to receive treatment with open-label Etrolizumab maintenance.
  • A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi­ Center Study to Investigate the Safety and Efficacy of APD334 [Sphingosine1PR1 modulator] tablet in Pts with Moderately to Severely Active CUC, with Arena Pharm

 

Crohn's Disease:

  • A Phase III Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 [MMP-9, gelatinase inhibitor] SC in Subjects with Moderately to Severely Active Crohn's Disease, with Gilead Pharm.: Patients completed the 8-week induction will be eligible for an open label extension receiving 150 mg of GS-5745 for 44 weeks.
  • A Phase III Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Combination RHB-104 tablet in Subjects with Moderately to Severely Active Crohn's Disease, with RedHill Biopharma:  RHB-104 consists of 3 antibiotics with activity against Mycobacterium avium subsp. paratuberculosis. Subjects with active CD will be randomized at baseline to receive up to 52 weeks of RHB-104 oral dose or placebo.
  • A Phase II Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of  ABT-494 [Janus kinase inhibitor] tablet for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crobn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy, with AbbVie Pharma.: The study will include a Screening up to 30 days and a double-blind induction of 16 weeks and an extension phase of 36 weeks.

 

Recurrent C. Difficile Associated Refractory Diarrhea:
  • A Study of Fecal Microbiota Transplantation by colonoscopy for the Treatment of Recurrent C. Difficile Associated Diarrhea.

Please contact the UTHMS GI Division, GI Research Manager Lacie Ford: Office # 713-500-6654 or Cell # 979-709-7076.