Gastroesophageal Reflux Disease (GERD)

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Gastroesophageal Reflux Disease (GERD)

General Purpose:

Chronic acid reflux (i.e., that which occurs more than twice per week) leads to repeated irritation of the esophageal lining and can result in serious damage to the tissue. This chronic form of acid reflux is known as gastroesophageal reflux disease, or GERD.

Symptoms of GERD are similar to those of occasional acid reflux, and include heartburn, sour taste in the mouth, chest pain, swallowing difficulty, dry cough, sore throat, hoarseness, regurgitation of food, and the sensation of a lump in the throat. However, the chronic irritation associated with GERD can also lead to bleeding, breathing problems, and pre-cancerous lesions in the esophagus.

Obesity, pregnancy, overeating, and the consumption of fatty or spicy foods can lead to the development of occasional acid reflux, however, certain individuals are at an increased risk of developing GERD, including those with asthma, diabetes, and various connective tissue disorders such as scleroderma (chronic hardening of the skin).

Additionally, smoking increases the likelihood of having acid reflux progress to GERD, as does the presence of a hiatal hernia (a hernia that occurs when a portion of the stomach pushes through the diaphragm), chronic dry mouth, and gastroparesis (a condition characterized by delayed stomach emptying).

A variety of medications (both prescription and non-prescription) are available to treat the symptoms associated with GERD. These include antacid medications that neutralize stomach acid (such as Maalox or Tums), as well as medications that decrease the amount of acid produced by the stomach (known as H-2-receptor blockers).

Examples of H-2-receptor blockers include Pepcid AC and Zantac. A group of medications known as proton pump inhibitors block acid production and provide time for the damaged areas of the esophagus to heal. These medications include Prevacid and Prilosec.

Researchers are constantly working to identify new and better methods of treating GERD, as well as refining existing treatment regimens. Better methods of diagnosing GERD are also being developed and tested.

What Will Gastroesophageal Reflux Disease Clinical Trials Be Like?

The types of tests and assessments used in gastroesophageal reflux disease clinical trials will ultimately depend on the specific nature of the study. Provided below is a list of frequent procedures and tests that may be used incorporated into clinical trials:

  • Physical exam and detailed medical history
  • Upper GI series: a series of x-rays performed after an individual has fasted for a period of time and then consumed a chalky-tasting liquid that makes the stomach and intestines more visible on x-ray.
  • Upper gastrointestinal (GI) endoscopy: a procedure during which a thin, flexible tube with a tiny light and camera attached to the end is fed down the mouth or nose, through the esophagus, and into the stomach and first part of the small intestine.
  • Ambulatory pH test: this procedure uses an acid-measuring device to determine the frequency and duration of stomach acid regurgitation into the esophagus. The monitor is often a thin, flexible tube that is threaded through the nose into the esophagus. It is hooked to a small computer worn around the waist, and takes approximately two days to perform.
  • Esophageal motility test: this test involves a similar tube as that which is used in an ambulatory pH test; however it measures the movement of and pressure within the esophagus.
  • You may be asked to take antacid medications, or refrain from taking antacid medications.
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Pain and quality of life assessments, as well as diet, exercise and/or medication diaries, may also be required in some studies, depending on the research question being studied.

Typical Gastroesophageal Reflux Disease Clinical Trial Protocol:

Specific examples of clinical trials for acid reflux disease might include the following:

  • A study to evaluate the effectiveness of a surgical treatment to strengthen and repair the esophageal sphincter in individuals with severe GERD.
  • A randomized clinical trial to determine if asthmatic individuals with GERD experience greater improvement in their symptoms when treated with a specific exercise and dietary intervention in addition to standard pharmaceutical therapy. In this study, patients would be randomly assigned to receive either the standard therapy plus the exercise/diet intervention, or standard therapy alone.
  • A randomized clinical trial to evaluate the effectiveness and safety of a new proton pump inhibitor in obese individuals who smoke. In this trial, patients receiving the new drug would be compared to patients receiving a placebo.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment (such as the second example provided above).

On occasion, a trial will investigate the use of a standard treatment plus a new drug or intervention, compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone (such as the third clinical trial example provided above). In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your history of gastroesophageal reflux disease (time since onset, specific diagnosis, etc.)
  • Your current medications (including aspirin), vitamins, and dietary supplements

Suggested Search Terms:

Once you are ready to begin your search for gastroesophageal reflux disease clinical trials, the following terms may be of use when combined with either “gastroesophageal reflux disease,” “GERD,” or “heartburn”:  “prevention,” “management,” “treatment,” “genetics,” “diet,” “exercise,” “diabetes,” “asthma,” “children,” “pediatric,” “pregnancy,” and “diagnosis,” and “surgery.”

Current Search Term:

“Gastroesophageal Reflux Disease (GERD)”

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A Trial of C13-CAC Breath Test in PPI Resistant GERD Patients


Condition:   Gastroesophageal Reflux Disease
Interventions:   Drug: Calcium (13C)Carbonate;   Drug: Gastric acid inhibitors
Sponsor:   Otsuka Pharmaceutical Co., Ltd.
Not yet recruiting


Correlates of GERD Symptom Severity


Condition:   GERD
Intervention:  
Sponsors:   Massachusetts General Hospital;   National Center for Complementary and Integrative Health (NCCIH)
Recruiting


Understanding the Pathophysiology and Effects of Diaphragmatic Breathing in Upright Gastroesophageal Reflux


Condition:   GERD
Interventions:   Behavioral: Diaphragmatic Breathing;   Behavioral: Sham Comparator
Sponsor:   Mayo Clinic
Not yet recruiting


STRETTA ,Radio Frequency Ablation (RFA) v/s Sham Therapy for the Treatment of Refractory GERD


Condition:   GERD
Interventions:   Device: Radio Frequency Ablation (RFA) (Stretta Procedure);   Procedure: Sham Procedure
Sponsor:   Asian Institute of Gastroenterology, India
Recruiting


Evaluation of Safety and Effectiveness of the RefluxStop Device in the Management of GERD


Condition:   GERD
Intervention:   Device: Treatment with RefluxStop
Sponsor:   Implantica CE & Production Ltd
Recruiting


Compound Sodium Alginate Oral Suspension Sachet 4-hour Esophageal pH Study in GERD Patients


Condition:   Gastro-esophageal Reflux Disease (GERD)
Interventions:   Drug: Compound Sodium Alginate Oral Suspension sachet;   Drug: Matched placebo
Sponsor:   Reckitt Benckiser Healthcare (UK) Limited
Terminated


Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease.


Condition:   Patients With Typical Symptoms of GERD (GERD Q >= 8)
Intervention:  
Sponsor:   AstraZeneca
Completed


GERD and Anti-Reflux Therapy Between Able-bodied and SCI Individuals


Condition:   Gastro Esophageal Reflux Disorder
Interventions:   Drug: Omeprazole;   Device: 24 Hour pH Monitor;   Procedure: Pulmonary Function Examination;   Procedure: Exhaled Nitric Oxide;   Procedure: Exhaled Breath Concentrate (EBC);   Procedure: Bernstein's Acid Clearance Test;   Procedure: Esophageal Motility
Sponsor:   James J. Peters Veterans Affairs Medical Center
Recruiting


The Primary Symptoms of GERD(Gastroesophageal Reflux Disease) in Chinese Outpatients in Gastroenterology Department


Condition:   Gastroesophageal Reflux
Intervention:   Drug: Esomeprazole MUPS, 20 mg
Sponsor:   First Affiliated Hospital, Sun Yat-Sen University
Recruiting


The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease


Condition:   GERD Gastroesophageal Reflux Disease
Interventions:   Drug: Omeprazole;   Device: LINX Reflux Management System
Sponsor:   Torax Medical Incorporated
Active, not recruiting


Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial


Condition:   Gastroesophageal Reflux Disease
Intervention:   Other: Study
Sponsors:   Sudarshan Jadcherla;   National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);   Ohio State University
Recruiting


Validation of a Non-invasive In-vitro Diagnostic Test (Peptest) Against Other Diagnostic Methods for GERD


Condition:   Gastro-esophageal Reflux Disease
Interventions:   Other: in vitro diagnostic test (Peptest);   Other: Questionnaire
Sponsors:   MAAB (Shanghai) Medical Device Limited;   RD Biomed Ltd
Active, not recruiting


Translation and Validation of the PASS Test for GERD Patients With Partial Response to PPI in Chinese Population: PASS-C


Condition:   Gastro-esophageal Reflux Disease
Intervention:  
Sponsor:   Chinese University of Hong Kong
Recruiting


A Study of Reflux Management With the LINX® System for Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy


Conditions:   GERD;   Gastroesophageal Reflux Disease
Intervention:   Device: LINX device
Sponsor:   Torax Medical Incorporated
Recruiting


Dietary Carbohydrate and GERD in Veterans


Conditions:   Gastroesophageal Reflux Disease;   Obesity
Intervention:   Other: Dietary Carbohydrate
Sponsor:   VA Office of Research and Development
Recruiting


The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study


Condition:   Gastroesophageal Reflux
Interventions:   Drug: PPI therapy;   Procedure: Stool sample
Sponsor:   Medical University of Graz
Completed


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


Conditions:   Gastroesophageal Reflux Disease;   GERD;   Acid Reflux;   Reflux
Intervention:   Drug: Quercetin
Sponsors:   University of North Carolina, Chapel Hill;   National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Completed


Registry to Compare Two Surgical Treatments for GERD


Condition:   GastroEsophageal Reflux Disease
Intervention:  
Sponsors:   American Gastroenterological Association;   EndoGastric Solutions
Terminated


A Prospective Blinded Randomized Study Comparing Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-y Gastric Bypass and Their Effect on Gastro-Esophageal Reflux Disease Using 24 Horus pH Monitoring


Condition:   GERD
Interventions:   Other: 24 pH monitoring;   Other: Esophageal Manometry:
Sponsor:   McMaster University
Suspended


A Post-Approval Study of the LINX® Reflux Management System


Condition:   Gastroesophageal Reflux Disease (GERD)
Intervention:   Device: LINX device
Sponsor:   Torax Medical Incorporated
Active, not recruiting


Prospective Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.


Condition:   Gastroesophageal Reflux Disease
Intervention:   Procedure: endoscopic full thickness plication
Sponsor:   Krankenhaus Barmherzige Schwestern Linz
Completed


Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy


Conditions:   Cerebral Palsy;   GERD
Interventions:   Drug: Baclofen;   Drug: placebo
Sponsors:   Boston Children’s Hospital;   National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Withdrawn


A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors


Condition:   GERD
Interventions:   Device: Nissen fundoplication;   Drug: baclofen;   Drug: Desipramine
Sponsor:   VA Office of Research and Development
Completed


Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment


Condition:   Gastroesophageal Reflux Disease (GERD)
Interventions:   Procedure: Transoral Incisionless Fundoplication;   Drug: Proton Pump Inhibitors; active control
Sponsors:   University of Pittsburgh;   EndoGastric Solutions;   Sandhill Scientific;   Crospon
Unknown status


Endoscopic Implantation of Enteryx for the Treatment of GERD


Condition:   Gastroesophageal Reflux
Intervention:   Drug: Enteryx
Sponsor:   Beth Israel Deaconess Medical Center
Completed

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