Can Quercetin Increase Claudin-4 and Improve Esophageal Barrier Function in GERD?

Purpose: To study whether quercetin, an herbal supplement, can be used to help treat gasteroesophageal reflux disease (GERD)
Principal Investigator: Dr. Nicholas J. Shaheen, MD, MPH
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Visit clinicaltrials.gov to learn more about Can Quercetin Increase Claudin-4 and Improve Esophageal Barrier Function in GERD?

Effect of Aspirin on Biomarkers of Barrett’s Esophagus After Successful Eradication of Barrett’s Esophagus with Radiofrequency Ablation

Purpose: To determine whether aspirin safely reduces the risk of re-developing BE after successful treatment.
Principal Investigator: Nicholas Shaheen, MD MPH

Visit ClinicalTrials.gov to learn more about the Aspirin Study

Oral Budesonide Suspension (OBS) in Adolescents and Adults with EoE

Purpose: To compare oral budesonide (OBS) to placebo to demonstrate that OBS improves dysphagia symptoms and induces a histologic response (in esophageal biopsies) over a 16 week course of therapy.
Principal Investigator: Evan Dellon, MD, MPH
Sponsor: Meritage Pharma, Inc

Visit ClinicalTrials.gov to learn more about this study OBS in Adolescents and Adults with EoE

Racial Disparity in Barrett’s Esophagus (BE)

Purpose: To investigate the molecular mechanisms of racial disparity in Barrett’s esophagus, the premalignant lesion of esophageal adenocarcinoma. Specifically, we hypothesize that environmental factors, genetic factors, and potentially gene environment interactions play crucial roles in the observed racial disparity in developing Barrett’s esophagus.
Principal Investigator: Nicholas Shaheen, MD MPH

Visit ClinicalTrials.gov to learn more about this study Racial Disparity in BE

Neosquamous Epithelium after Ablation

Purpose: To compare the morphological and functional aspects of the neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett’s esophagus (BE) to that of native squamous epithelium in normal controls as well as gastroesophageal reflux disease (GERD), non-Barrett’s Esophagus (BE) subjects.
Principal Investigator: Dr. Nicholas Shaheen
Sponsors and Collaborators: American Society for Gastrointestinal Endoscopy

Visit ClinicalTrials.gov to learn more about this study Neosquamous Epithelium after Ablation

Ursodiol in Treating Patients with Barrett’s Esophagus (BE)

Purpose: To show how well ursodiol, a medication, works in treating patients with Barrett’s esophagus in a phase II trial.
Principal Investigator: Dr. Nicholas Shaheen
Sponsors and Collaborators: National Cancer Institute

Visit ClinicalTrials.gov to learn more about this study Ursodiol in Treating Patients with BE

An Epidemiologic Case-Control Study of Barrett’s Esophagus

Purpose: To study why some people with reflux symptoms (such as heartburn) go on to develop a pre-cancerous change in their esophagus, called Barrett’s esophagus, while others do not.
Principal Investigator: Dr. Nicholas Shaheen
Sponsors and Collaborators: National Institutes of Health

Correlation of FISH Analysis with Dysplasia in Subjects with Barrett’s Esophagus (BE)

Purpose: To learn about genetic alterations and tumor suppressor genes in subjects with Barrett’s esophagus and various grades of dysplasia.
Principal Investigator: Dr. Nicholas Shaheen
Sponsors and Collaborators: NeoGenomics, Inc

Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE); Esophageal Medication Distribution, Treatment Response, and Effect on the Adrenal Axis

Purpose: To compare two formulations of budesonide (nebulized/swallowed versus viscous/swallowed) in patients with EoE to determine if medication contact time and distribution in the esophagus relates to treatment response.
Principal Investigator: Dr. Evan Dellon
Sponsors and Collaborators: AstraZeneca

Visit ClinicalTrials.gov to learn more about this study Topical Budesonide Treatment for EoE

Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease (GERD)

Purpose: To learn if a very low carbohydrate (sugar) diet or traditional low fat diet is able to reduce symptoms related to gastroesophageal reflux disease (GERD) in people who are overweight.
Principal Investigator: Dr. Nicholas Shaheen
Sponsors and Collaborators: National Institutes of Health and Takeda Pharmaceuticals

Visit ClinicalTrials.gov to learn more about this Study to Evaluate the Effect of a Very Low Carb Diet on GERD

Relationship of Intragastric Acid Control and Healing Status of Moderate and Severe Erosive Esophagitis After Treatment with Esomeprazole Magnesium (NEXIUM^®) 10 mg and 40 mg Once Daily

Purpose: To determine if controlling stomach acid is related to healing of erosive esophagitis after treatment with esomeprazole magnesium (Nexium^®) 10 mg and 40 mg once daily.
Principal Investigator: Dr. Nicholas Shaheen
Sponsors and Collaborators: AstraZeneca LP

Dose Finding Study to Assess the Effect of Different Doses of Lesogaberan (AZD3355) as Add-on to PPI in GERD Patients with Partial Response to PPI

Purpose: To study whether AZD3355 is effective in treating GERD if added to the normal treatment with PPIs and if so, how it compares with PPI treatment alone.
Principal Investigator: Dr. Nicholas Shaheen
Sponsors and Collaborators: AstraZeneca

Visit ClinicalTrials.gov to learn more about this study to Assess the Effect of Different Doses of AZD3355 as add-on to PPI in GERD Patients with Partial Response to PPI

Clinical Risk Factors for Barrett’s Esophagus in a Primary Care Setting

Purpose: To learn about the risk factors associated with the development of Barrett’s Esophagus (BE) and to determine the true prevalence (how often a disease occurs in the general population) of BE.
Principal Investigator: Dr. Nicholas Shaheen
Sponsors and Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases-Division of Digestive Diseases and Nutrition (NIDDK-DDDN)

The Utility of Nexium in Chronic Cough and Reflux Disease

Purpose: To study whether different doses of proton pump inhibitor, Esomeprazole (Nexium), reduce cough symptoms felt to be associated with gastroesophageal reflux disease (GERD).
Principal Investigator: Dr. Nicholas Shaheen
Sponsors and Collaborators: AstraZeneca

Visit ClinicalTrials.gov to learn more about this study The Utility of Nexium in Chronic Cough and Reflux Disease

The Impact of Gastroesophageal Reflux Disease (GERD) in Sleep Disorders

Purpose: To study whether GERD causes sleep disturbances and the effect of rabeprazole (Aciphex), a medication that lowers the amount of acid in the stomach.
Principal Investigator: Dr. Nicholas Shaheen
Sponsors and Collaborators: Janssen Pharmaceutical and Eisai, Inc.

Visit ClinicalTrials.gov to learn more about this study The Impact of GERD in Sleep Disorders

Risk Perception of Barrett’s Esophagus (BE)

Purpose: To assess patients’ perceptions of cancer risk in the setting of BE at three U.S. clinical sites and to relate patients’ perception of cancer risk to how they utilize the healthcare system.
Principal Investigator: Dr. Nicholas Shaheen
Sponsors and Collaborators: National Institutes of Health (NIH)

A Study to Assess the Efficacy, Safety, and Tolerability of Tegaserod Alone and in Combination with Omeprazole Given Orally in Patients With Symptoms of Symptomatic Gastroesophageal Reflux Disease (sGERD)

Purpose: To study the use of omeprazole (Prilosec) and tegaserod (Zelnorm) in people who have symptomatic (non-erosive) gastroesophageal reflux disease (sGERD)
Principal Investigator: Dr. Nicholas Shaheen
Sponsors and Collaborators: Novartis Pharmaceuticals Corporation

Visit ClinicalTrials.gov to learn more about this studyTo Assess the Efficacy, Safety, and Tolerability of Tegaserod Alone and in Combination with Omeprazole in Patients with GERD

Efficacy and Safety of Dexlansoprazole Modified Release (MR) Formulation Compared to Placebo on Symptom Relief in Subjects with Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)

Purpose: To investigate the safety and efficacy of daily treatment with dexlansoprazole MR (slow release) in subjects with gastroesophageal reflux disease
Principal Investigator: Dr. Nicholas Shaheen
Sponsors and Collaborators: Takeda Pharmaceuticals (Formerly TAP Pharmaceutical Products Inc)

Visit ClinicalTrials.gov to learn more about this study Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn

Can Detection of Fragments of Cleaved E-cadherin in Tissue and/or Blood be of Value for Identifying and Monitoring Patients with PPI-Responsive Heartburn?

Purpose: To learn more about a type of protein (E-cadherin) that may be related to heartburn and to find out if the amount of this protein in blood and tissue can determine if proton pump inhibitor (PPI) medications will be helpful in treating the heartburn.
Principal Investigator: Dr. Roy Orlando
Sponsors and Collaborators: Takeda Pharmaceuticals

Visit ClinicalTrials.gov to learn more about this study Can Detection of Fragments of Cleaved E-cadherin in Tissue and/or Blood be of Value for Identifying and Monitoring Patients with PPI-Responsive Heartburn?

Effect of Omeprazole Magnesium 20mg (Prilosec OTC®) on Esophageal Healing in Non-Erosive Frequent Heartburn

Purpose: To better understand if omeprazole, when used for short periods of time, is capable of healing the invisible or microscopic esophageal damage sometime caused by GERD compared to a placebo (an inactive substance).
Principal Investigator: Dr. Nicholas Shaheen
Sponsors and Collaborators: Procter and Gamble, Inc.

Mechanisms of Acid Resistance in Barrett’s Esophagus (BE): Endoscopic Biopsy

Purpose: To collect biopsies from the esophagus of patients with BE in order to better understand cellular changes which occur with this condition, and how these cellular changes affect patients with this condition.
Principal Investigator: Dr. Roy Orlando
Sponsors and Collaborators: National Institutes of Health (NIH)

Defective Barrier Function in Neosquamous Epithelium (NSE): A Risk Factor for Recurrent Barrett’s Esophagus (BE)

Purpose: To learn more about the lining of the esophagus in people who have had BE and have received radiofrequency ablation for the condition 3 or more months ago.
Principal Investigator: Dr. Roy Orlando
Sponsors and Collaborators: National Institutes of Health (NIH)

Do Acid Sensing Ion Channels (ASICs) Contribute to Heartburn in Patients with Proton Pump Inhibitor (PPI)-Compete Responders or PPI-Partial Responders with Nonerosive Reflux Disease (NERD)?

Purpose: To learn about whether treating the esophagus with amiloride reduces either the frequency or the time to onset of acid-induced heartburn in patients with nonerosive reflux disease.
Principal Investigator: Dr. Roy Orlando
Sponsors and Collaborators: AstraZeneca

Visit ClinicalTrials.gov to learn more about this study Do Acid Sending Ion Channels (ASICs) contribute to heartburn in patients?

Prevalence of Dysplasia of the Gastric Cardia

Purpose To determine the prevalence of metaplasia and dysplasia in the gastric cardia before and after ablative therapy. To determine the incidence of cardiac metaplasia and dysplasia as a function of ablative therapy. To determine the correlation between dysplasia in the tubular esophagus, and dysplasia in the cardia.
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: CSA Medical, Inc.

Visit clinicaltrials.gov to learn more about Prevalence of Dysplasia of the Gastric Cardia

A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett’s Esophagus with trūFreeze™ Spray Cryotherapy (DOSE Study)

Purpose: This post-marketing study is being conducted to determine the optimum starting dose of spray cryotherapy for the treatment of dysplastic Barrett’s Esophagus (BE). Patients undergoing ablation with the FDA-approved truFreezeTMcryotherapy device will be assigned to receive one of four pre-determined starting doses of cryotherapy. All doses used in the study fall within the currently recommended therapeutic range for the treatment of BE.
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: CSA Medical, Inc.

CSA TruFreeze Website

Visit clinicaltrials.gov to learn more about DOSE Study

Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese (ENDO study)

 Purpose: To determine if the EndoBarrier device safely and effectively improves glycemic control in obese subjects with type 2 diabetes
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: GI Dynamics

Visit clinicaltrials.gov to learn more about ENDO study

Use of Radiofrequency Ablation for Roux-en-Y Gastric Bypass (RGB)

Purpose: To gather information regarding the safety and effectiveness of radiofrequency ablation to produce further weight loss after a gastric bypass
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: Covidien, GI Solutions

Visit clinicaltrials.gov to learn more about Use of Radiofrequency Ablation for RGB

Effect of Dexlansoprazole (Dexilant) on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett’s Esophagus (BE) with Radiofrequency Ablation

Purpose: To study the effect of once daily versus twice daily dexlansoprazole (Dexilant) dosing on the recurrence of intestinal metaplasia (IM) in subjects who achieved complete eradication of Barrett’s esophagus (BE) with high-grade dysplasia (HGD) following radiofrequency ablation (RFA).
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: Takeda

Visit clinicaltrials.gov to learn more about Effect of Dexilant on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of BE with Radiofrequency Ablation

Wide Area Transepithelial Sample Esophageal Biopsy combined with computer assisted 3-dimensional analysis (WATS) For the Detection of Esophageal Dysplasia

Purpose: This is a multi-center study to determine if the combination of WATS and “random biopsies” will have a higher detection rate of Barrett’s associated neoplasia (high grade dysplasia/esophageal adenocarcinoma) compared to “random biopsies” alone.
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: CDx Diagnostics

Stratifying risk in Barrett’s Esophagus: A pilot study for biomarker-based patient management

Purpose: To gather information on the feasibility of a prospective, international multicenter study in which, on the basis of biomarker-based risk stratification, patients at high risk for progression are randomized to radiofrequency ablation (RFA) vs. a yearly surveillance EGD arm, while patients in the low risk group have an attenuated EGD surveillance regimen per current standard of care.

Principal Investigator: Dr. Nicholas Shaheen, MD, MPH

Sponsor: American Society for Gastrointestinal Endoscopy (ASGE)

Visit clinicaltrials.gov to learn more about Stratifying Risk in BE Pilot Study