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Irritable Bowel Syndrome (IBS)

About Irritable Bowel Syndrome (IBS) Clinical Trials (Click to Open)

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Irritable Bowel Syndrome (IBS)

General Purpose:

Irritable bowel syndrome (IBS) is a disorder of the bowel (i.e., large intestine) that is characterized by severe abdominal pain and cramping, changes in bowel movements, and numerous other symptoms that vary between individuals, including abdominal fullness, gas, and bloating, as well as changes in appetite.

Symptoms are usually relieved or improved following a bowel movement. Constipation and diarrhea are also frequently experienced by individuals by IBS. For many people, symptoms wax and wane, while for others they remain constant.

The majority of cases of IBS have no known cause, although IBS has been known to occur following intestinal infection. In addition, some research suggests that malfunctioning nerves that control the movement of material through the intestines may also be involved.

IBS can also occur following a stressful life event, and may also result from the body’s inability to perceive pain correctly. Certain dietary factors may also trigger IBS, including celiac disease (gluten sensitivity), wheat-containing foods, dairy, and/or yeast.

IBS is very common and affects roughly one out of six people in the United States. It typically starts in the teens and early adult years, and affects women twice as often as men. Treatments for IBS are focused on relieving symptoms and generally incorporate a combination of lifestyle and behavioral changes and medication.

What Will Irritable Bowel Syndrome Clinical Trials Be Like?

The types of tests and assessments used in IBS 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
  • Blood tests may be performed to detect exceptionally high levels of certain antibodies (immune system cells that work to eliminate foreign substances).
  • Biopsy of intestinal tissue
  • 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 small intestine.
  • Some studies may require that patients swallow a small camera-containing pill that takes thousands of pictures while inside the body, and transmits them to a receiver worn on the patient’s belt. The pill is then excreted from the body in the stool. 
  • 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.
  • Lifestyle interventions, such as increased sleep, increased exercise, elimination of stimulants such as caffeine, decreasing meal portion sizes, and increasing dietary fiber intake.
  • 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 Irritable Bowel Syndrome Clinical Trial Protocol:

Specific examples of clinical trials for IBS might include the following:

  • A randomized clinical trial in which an investigational drug is evaluated to determine its effectiveness, safety, and tolerability when used to treat IBS patients whose disease is characterized predominantly by the occurrence of diarrhea (known as diarrhea-predominant IBS). In this study, half of the patients would be randomly assigned to receive the investigational medication, while the other half would be assigned to receive a placebo.
  • A study to determine the effectiveness of a newly-developed antidepressant medication for the treatment of irritable bowel syndrome in individuals who also have generalized anxiety disorder (GAD).
  • A clinical trial to determine the effectiveness of adding peppermint oil extract supplements to conventional pharmaceutical treatment for IBS. In such a study, half of the patients would be randomly assigned to receive standard pharmaceutical treatment plus the peppermint oil supplements, while the other half would be assigned to receive standard treatment plus a placebo.
  • A study to investigate whether a high-fiber, low-gluten diet is effective at improving the frequency and severity of IBS-related symptoms among females between the ages of 18 and 30.

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 (such as the third clinical trial example provided above). 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 first 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 predominant symptoms associated with IBS
  • The length of time you have had IBS
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your current dietary habits (gluten-free, reduced gluten diet, etc.)

Suggested Search Terms:

Once you are ready to begin your search for IBS-related clinical trials, the following terms may be of use when combined with the phrase “irritable bowel syndrome”: “prevention,” “management,” “treatment,” “genetics,” “diet,” “pediatric,” “diagnosis,” “nutrition,” “vitamin,” “screening,” “surgery,” “infection,” and “alternative therapies.” 

Current Search Term:

“Irritable Bowel Syndrome (IBS)”

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