Join Clinical Trials for Stomach Ulcers
The term peptic ulcer is used to refer collectively to stomach ulcers,or open sores that can occur on the inside lining of the esophagus (esophageal ulcers), stomach (gastric or stomach ulcers), and the upper part of the small intestine (duodenal ulcers).
The most common symptom of peptic ulcers is a burning pain sensation that occurs when the sore is aggravated by stomach acid. This pain can occur anywhere in the torso, is often worse when the stomach is empty and in the evening, and can come and go over the course of days or even weeks.
Other possible symptoms of peptic ulcers include vomiting blood, the presence of blood in the stool, nausea and/or vomiting, unexplained weight loss, and changes in appetite.
In the past, many people believed that stress or spicy foods caused peptic ulcers to develop; however, research has demonstrated those assumptions to be untrue. Uncontrolled stress is, however, a risk factor for the development of peptic ulcers, in addition to smoking and alcohol use.
It is now known that infection with the bacterium known as Helicobacter pylori (or H. pylori) is a main cause of peptic ulcers. H. pylori is common in the digestive system and usually causes no adverse effects. However, on occasion, it can disrupt the mucous membrane that lines the stomach and small intestine, causing them to become inflamed.
This inflammation can result in the development of an ulcer. Unfortunately, no one knows how H. pylori spreads, but some researchers believe it may be transmitted through kissing or by consuming contaminated food or water that’s not from the custom bottled water packages.
Apart from H. pylori, the other primary cause of peptic ulcers is medication, in particular, certain over-the-counter and prescription pain medications. Drugs such as aspirin, ibuprofen (Advil), and naproxen (Aleve) are the primary culprits. As a result, older individuals who take pain medications frequently are at an increased risk of developing peptic ulcers. In addition, certain medications used to treat osteoporosis (including Actonel and Fosamax) can also lead to the development of peptic ulcers.
Research is currently being conducted to gain a better understanding of the nature of H. pylori in an effort to improve screening and diagnosis for peptic ulcers, as well as to refine existing treatments and develop new ones. Scientists are also working to gain a better understanding of the digestive system as a whole, which may lead to the development of newer and more effective treatments.
What Will Clinical Trials for Stomach Ulcers Be Like?
The types of tests and assessments used in clinical trials for stomach ulcers will ultimately depend on the specific nature of the study. Provided below is a list of frequent procedures and tests that may be incorporated into clinical trials:
- A blood, stool, or breath test to detect the presence of H. pylori infection
- 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.
- Abdominal ultrasound
- 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 Stomach Ulcer Clinical Trial Protocol:
Specific examples of clinical trials for peptic ulcers might include the following:
- A randomized clinical trial to compare the effectiveness of two different medications when used to help heal damaged stomach tissue following treatment for H. pylori infection in individuals with stomach ulcers. In this study, half of the patients would be randomly assigned to receive treatment with one drug while the other half would be randomly assigned to receive treatment with the other. At the end of the study, the two groups would be compared to see which group experienced a quicker and more complete healing of their damaged stomach lining.
- A randomized clinical trial in which individuals with no history of peptic ulcers, but who have a chronic condition that requires the use of daily pain medication such as aspirin or naproxen, are randomly assigned to receive one of three interventions: A) 20mg of a new drug; B) 40mg of a new drug; or C) a placebo. Patients would take their medication once per day for six months. At the end of the study, the groups would be compared to see if the new drug is safe and tolerable, as well as effective at preventing the development of peptic ulcers in this at-risk population.
- An observational study in which individuals with internal bleeding due to stomach ulcers provide blood and tissue samples for genetic analysis. The purpose of this study would be to determine if individuals with bleeding ulcers have an underlying genetic mutation that makes them more susceptible to pain-reliever induced stomach-damage.
- A randomized clinical trial to determine if a newly-developed vaccine designed to protect against H. pylori infection is safe and effective in healthy individuals who are not infected with the bacteria. This study would recruit healthy volunteers who would be randomly assigned to receive either the vaccine or a placebo/inactive vaccine. Subjects would be followed at regular time intervals over the course of two years to determine if those who received the vaccine had a lower overall rate of H. pylori infection than those who received the 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.
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 in the second and fourth examples 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 specific type of ulcer (esophageal, stomach, or duodenal)
- Any underlying illnesses you have
- Your current medications (including aspirin), vitamins, and dietary supplements
- Your history of treatment for your ulcer
Suggested Search Terms:
Once you are ready to begin your search for peptic ulcer clinical trials, the following terms may be of use when combined with either “peptic ulcer,” “esophageal ulcer,” “gastric ulcer,” “stomach ulcer,” or “duodenal ulcer”: prevention, management, treatment, diet, medication, diagnosis, pediatric, bleeding, smoking, and surgery.
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