Ongoing Clinical Trials

Recurrent Clostridium difficile Infection

The Program for Restoration of Intestinal Microbata is conducting clinical trials for patients with recurrent Clostridium difficile infection.
Principal Investigator: Herbert L. Dupont, MD
Phone: 713-442-1220
Target Population: Individuals with at least 3 documented recurrences of CDI in the past year inclusive of the recurrent CDI episode or at least 2 episodes of severe CDI resulting in hospitalization, a positive C. difficile toxin test report for most recent CDI (within last 60 days) and at least 2 positive additional C. difficile test reports; and who have completed at least 2 rounds of standard-of-care antibiotic (vancomycin or fidaxomicin) therapy.

Ulcerative Colitis

A long term non interventional registry to assess safety and effectiveness of Humira (Adalimumab) in patients with moderately to severely active Ulcerative Colitis (UC)
Sponsor: Abbvie
Principal Investigator: Andrew W. DuPont, MD, MSPH
Study Coordinator: Urvashi Patel-Knox
Email: GI.Research@uth.tmc.edu
Phone: 713-500-6679
Main Inclusion Criteria:

  • Adults with moderately to severely active UC
  • Currently taking HUMIRA for at least 8 weeks before enrollment
  • Currently taking IMM (6-MP or AZA) without a concurrent biologic for at least 12 consecutive weeks of IMM therapy.

Ulcerative Colitis

Entyvio (vedolizumab) long-term safety study: An international observational prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or Crohn’s Disease
Sponsor: Tekeda Development Center Americas
Principal Investigator: Atilla Ertan, MD, MACG, AGAF, FACP
Study Coordinator: Urvashi Patel-Knox
Email: GI.Research@uth.tmc.edu
Phone: 713-500-6679
Main Inclusion Criteria: Patients with UC or CD who are initiating vedolizumab therapy or another biologic agent for UC or CD.

Ulcerative Colitis

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis
Sponsor: Gilead Sciences, Inc.
Principal Investigator: Atilla Ertan, MD, MACG, AGAF, FACP
Study Coordinator: Urvashi Patel-Knox
Email: GI.Research@uth.tmc.edu
Phone: 713-500-6679
Main Inclusion Criteria: Male subjects between the ages of 25 and 55; Documented diagnosis of UC of at least 6 months; Provide semen samples.

Ulcerative Colitis

Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis
Sponsor: Gilead Sciences, Inc.
Principal Investigator: Atilla Ertan, MD, MACG, AGAF, FACP
Study Coordinator: Urvashi Patel-Knox
Email: GI.Research@uth.tmc.edu
Phone: 713-500-6679
Main Inclusion Criteria:

  • Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge
  • Moderately to severely active UC as determined by a centrally read endoscopy score ≥ 2, a rectal bleeding score ≥ 1, a stool frequency score ≥ 1 and PGA of ≥ 2

Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis
Sponsor: Gilead Sciences, Inc.
Principal Investigator: Atilla Ertan, MD, MACG, AGAF, FACP
Study Coordinator: Urvashi Patel-Knox
Email: GI.Research@uth.tmc.edu
Phone: 713-500-6679
Main Inclusion Criteria:

  • Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for UC.

Crohn’s Disease

A Long Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease
Sponsor: Gilead Sciences, Inc.
Principal Investigator: Atilla Ertan, MD
Study Coordinator: Urvashi Patel- Knox
Email: GI.Research@uth.tmc.edu
Phone: 713-500-6679

Crohn’s Disease

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness of a Nutritional Intervention in Improving the Intestinal Mucosal Health Status in Subjects with Crohn’s Disease (CD) Receiving Induction Anti-TNF Therapy
Sponsor: Nestec Ltd and its affiliate Prometheus Laboratories Inc.
Principal Investigator: Andrew W. DuPont, MD, MSPH
Study Coordinator: Jordan Varing
Email: GI.Research@uth.tmc.edu
Phone: 713-500-6676
Main Inclusion Criteria:

  • CDAI score ≤ 300
  • Active endoscopic disease (SES-CD score ≥ 6) documented during the study screening phase or -SES-CD score ≥ 4 if isolated ileal disease
  • Induction of Infliximab or adalimumab therapy within 24 weeks prior to randomization

Crohn’s Disease

Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease
Sponsor: Gilead Sciences, Inc.
Principal Investigator: Atilla Ertan, MD, MACG, AGAF, FACP
Study Coordinator: Urvashi Patel-Knox
Email: GI.Research@uth.tmc.edu
Phone: 713-500-6679
Main Inclusion Criteria:

  • Documented diagnosis of CD with a minimum disease duration of 6 months with involvement of the ileum and/or colon at a minimum
  • Moderately to severely active CD determined by CDAI 220 to 450 (inclusive), AND PRO2 (abdominal pain score ≥ 2 [on a scale of 0 to 3] OR stool frequency ≥ 4), AND centrally read SES-CD score ≥ 6 (or ≥ 4 if disease is limited to the ileum and/or right colon)
  • Must not have ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
  • Must not have active tuberculosis (TB) or history of latent TB that has not been treated

Short Bowel Syndrome

A prospective, multi-center registry for patients with short bowel syndrome (SBS)
Sponsor: NPS Pharmaceuticals
Principal Investigator: Andrew W. DuPont, MD, MSPH
Study Coordinator: Urvashi Patel-Knox
Email: GI.Research@uth.tmc.edu
Phone: 713-500-6679
Main Inclusion Criteria:

  • Diagnosis of short bowel syndrome

Non-Alcoholic Steatohepatitis (NASH)

A Phase 3, double-blind, randomized, long-term, placebo-controlled, multicenter study evaluating the safety and efficacy of Obeticholic Acid in subjects with Nonalcoholic Steatohepatitis
Sponsor: Intercept
Principal Investigator: Moises Ilan Nevah Rubin, MD
Study Coordinator: Urvashi Patel-Knox
Email: GI.Research@uth.tmc.edu
Phone: 713-500-6679
Main Inclusion Criteria:

  • Evidence of NASH on a liver biopsy obtained no more than 6 months
  • Evidence of fibrosis stage 2
  • Either not taking or is on stable doses of TZDs/ glitazones (DM type II) or vitamin E for 6 months

Non-Alcoholic Steatohepatitis (NASH)

A Phase 2 Double-Blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability and Efficacy of Volixibat Potassium, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi) in Adults with Nonalcoholic Steatohepatitis (NASH) 
Sponsor: Shire Human Genetic Therapies, Inc.
Principal Investigator: Victor Machicao, MD
Study Coordinator: Urvashi Patel-Knox
Email: GI.Research@uth.tmc.edu
Phone: 713-500-6679

Primary Biliary Cirrhosis

A Phase 3b, double-blind, randomized, placebo-controlled, multicenter study evaluating the effect of Obeticholic Acid on clinical outcomes in subjects with Primary Biliary Cirrhosis
Sponsor:  Intercept
Principal Investigator: Moises Ilan Nevah Rubin, MD
Study Coordinator: Urvashi Patel-Knox
Email: GI.Research@uth.tmc.edu
Phone: 713-500-6679
Main Inclusion Criteria:

  • PBC dx for 6 months
  • Positive AMA titer
  • Liver biopsy consistent with PBC

Hepatitis C

A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/ Pibrentasvir (PIB) in Treatment Naïve Adults with Chronic Hepatitis C Virus (HCV) Genotype 1,2,4,5 or 6 infection and Compensated Cirrhosis
Sponsor:  AbbVie Inc.
Principal Investigator: Moises Ilan Nevah Rubin, MD
Study Coordinator: Urvashi Patel-Knox
Email: GI.Research@uth.tmc.edu
Phone: 713-500-6679