Clinical Research

The physicians of Main Line Gastroenterology Associates are actively involved in clinical research. This page lists the research protocols that are ongoing. Patients wishing to inquire about, or volunteer to be subjects in our research studies should call either their doctor or one of our research coordinators, at 215-723-8580.

Help us explore an investigational medication for ulcerative colitis

We are looking for adults with active symptoms of ulcerative colitis who want to help people with this condition in the future

If this describes you, then you may be able to take part in the varsity study – a clinical research study looking at the effects of two different investigational medications for ulcerative colitis (UC). These medications (in the doses being used in this study) have been approved to be prescribed by doctors in many countries for moderately to severely active UC. However, use of these medications in this study is investigational. 

You may be able to take part in the varsity study if you:

  • are 18–80 years of age (inclusive)
  • have been diagnosed with UC
  • have previously received, or are currently receiving, treatment that has failed to treat your symptoms of UC.

Your health will be monitored throughout the study by a team of doctors and nurses. You will receive investigational medication, and all study-related health assessments, at no cost.

To find out more, please contact The Clinical Department of Main Line G.I. at 610-232-0442

Celiac Trial

A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Patients with Celiac Disease who have persistent symptoms despite being on a gluten-free diet.

Inclusion Criteria: (not all inclusive)

  • Biopsy proven and serology-confirmed celiac disease (at any point in time prior to study entry)
  • Written informed consent
  • Age between 18 - 75
  • BMI between 18.8 - 40
  • Symptoms despite being on a gluten-free diet (diarrhea, nausea, stomach pain, bloating)
  • Must have attempted a gluten-free diet for at least 12 months

Exclusion Criteria: (not all inclusive)

  • Refractory Celiac Disease
  • Diagnosed with chronic active GI disease, such as irritable bowel syndrome, inflammatory bowel disease etc.
  • Severe complications of celiac diseases

Secure Registry Trial

A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease. The purpose of this study is to monitor safety outcomes of patients who have taken Cimzia® as compared to a non-Cimzia® control population. The SECURE Registry's target enrollment is 4000 patients and it's objective is to monitor patients for approximately 10 years.

Inclusion Criteria: (not all inclusive)

  • Patient must have medically documented Crohn's disease
  • The decision to prescribe Cimzia or other medications has been made by the physician independent of inclusion in the study
  • Cimzia Cohort: Patient about to receive treatment with Cimzia® as part of pre-existing management plan for Crohn's disease or has already been receiving treatment with Cimzia® for < 6 months.
  • Comparison cohort: Patient must be about to receive treatment with any other medication as part of a pre-existing management plan for Crohn's disease or has already been receiving treatment (previous Cimzia® treatment is prohibited).

Hepatitis C Observational Study

Comparative Assessment of Effectiveness of Antiviral Therapies in Hepatitis C (COMPASS)

The aim of this study is to evaluate the "real world" treatment patterns and outcomes in Hepatitis C patients, to quantify and compare real world sustained viral response rates with direct acting antiviral. Patients will be followed during the duration of therapy (up to 48 weeks depending on treatment) and for an additional 32 weeks following the end of treatment.

Inclusion Criteria:

  • Patients must be 18 yrs or older
  • Diagnosis of CHC with documented positive HCV RNA
  • Initiating treatment for Hepatitis C

Exclusion Criteria:

  • History of Liver Transplant
  • Co-infection with HIV or Hepatitis B
  • Hepatocellular carcinoma
  • Acute Hepatitis
  • Other non-HCV liver disease
  • End stage renal disease Autoimmune disease know to be exacerbated by Alfa/RBV Severe
  • Hemoglobinopathies and anemia