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About Constipation Clinical Trials (Click to Open)

Join Clinical Trials for Constipation


General Purpose:

The term constipation refers to infrequent bowel movements or the difficult passing of stools. It is extremely common and can occur as a result of a number of factors. The primary cause of constipation is the slow movement of waste through the digestive tract, which causes it to become hard, dry, and difficult to pass.

Conditions that cause the muscle contractions of the colon (i.e., large intestine) to be slower than normal, or uncoordinated, can also result in constipation. Dehydration and a diet low in fiber can also lead to constipation.

Other causes of, and risk factors for, constipation include decreased physical activity, increasing age, pregnancy, irritable bowel syndrome (IBS), and frequent use or misuse of laxatives. Diabetes, thyroid disease, and hormonal imbalances can also predispose individuals to constipation.

Certain medications (including many sedatives, narcotic pain medicines, and blood pressure-lowering drugs) can also have constipation as a side effect. Chemotherapy can also cause considerable constipation in some people. Finally, children are also affected by constipation – more frequently than adults in fact. Constipation in children often results from a fear or unwillingness to use the toilet, or inattention to the urge to have a bowel movement.

Chronic constipation can result in a number of complications, including hemorrhoids or fissures (cracks) in the anus, impacted fecal matter that may require manual removal, and rectal prolapse (a condition that occurs when a small amount of rectal tissue pushes out through the anus).

For most people, effective treatments include straightforward dietary and lifestyle modifications to relieve symptoms. These include eating a high-fiber diet (at least 20 to 35 grams of fiber each day), performing regular physical activity, staying well-hydrated, and making time for bowel movements.

When these changes are not effective, over-the-counter laxatives (including fiber supplements, stimulants, lubricants, and stool softeners) may also be helpful. It is important to note, however, that many can be habit-forming and some can lead to long-term complications if used more frequently than needed.

Prescription medications are also available, including drugs known as chloride channel activators and 5-HT-4 agonists. Medical procedures, such as enemas, manual clearing of the colon, and surgery are infrequently required but may be a possibility when all other attempts at treatment have proven unsuccessful.

If you suffer from chronic constipation, take comfort in the fact that clinical trials are available for your condition and may be able to help you. Researchers are hard at work testing new treatment options, as well as studying new ways to diagnose constipation. They are also working to gain a better understanding of the various underlying conditions that can lead to constipation.

What Will Constipation Clinical Trials Be Like?

The types of tests and assessments used in constipation 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 incorporated into clinical trials:

  • Physical exam and detailed medical history
  • Barium enema X-ray: this procedure involves the use of a barium-containing enema, which coats the bowels and allows them to be more visible on x-ray.
  • Defecography: this refers to an x-ray of the anal and rectal areas, during which the patient expels a soft paste (similar in consistency to stool), so that the functioning of the rectal muscles can be evaluated via x-ray.
  • Sigmoidoscopy: a procedure during which a thin, flexible tube with a tiny light and camera attached to the end is inserted into the anus in order to examine the rectum and the lower portion of colon.
  • Anorectal manometry: a procedure during which a thin, flexible tube is inserted into the anus and rectum, and then a small balloon at the tip of the tube is inflated. The physician then pulls the tube back through the anus to measure how effectively the muscles coordinate to move the bowels.
  • Colorectal transit study: this procedure involves swallowing a tiny capsule, the contents of which are visible on x-ray. A series of x-rays are taken over several days which allows the physician to observe how well food moves through the colon.
  • 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 Constipation Clinical Trial Protocol:

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

  • A randomized clinical trial to evaluate the effectiveness of probiotic bacteria (similar to the active cultures found in yogurt) in children who suffer from chronic abdominal pain due to constipation. In such a study, half of the children would be randomly assigned to receive treatment with the bacterial medication, while the other half would be randomly assigned to receive a placebo.
  • An observational study in which elderly patients living in nursing homes are evaluated to determine how their medication regimens, nutrition, physical activity level, demographics, and concurrent illnesses are related to the frequency of constipation.
  • A randomized clinical trial in which a new drug is compared to standard pharmaceutical treatment for constipation among orthopedic patients who are receiving narcotic pain medications for pain control following surgery. In such a study, half of the patients would be randomly assigned to receive the new drug plus the standard therapy, while the other half would be randomly assigned to receive the standard therapy plus a placebo.
  • Randomized clinical trial to determine how the body metabolizes a newly-developed drug currently being tested for its ability to increase the transit time of waste through the intestines. In such a study, four groups of patients would be randomly assigned to receive either one of three doses of the drug, or a placebo. Blood tests would be drawn at specified intervals to observe how the drug is metabolized by the body, and tests would be administered to patients to determine how effectively their digestive tract moved contents during the course of treatment.

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 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 (such as the first example provided above), the investigational treatment might be compared to a placebo alone. 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 constipation
  • Any underlying illnesses you have
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your history of treatment for constipation (including use of fiber supplements, laxatives, and diet/exercise modifications)

Suggested Search Terms:

 “constipation prevention,” “constipation management,” “constipation treatment,” “constipation diet,” “constipation exercise,” “constipation disease,” “constipation children,” “constipation pediatric,” “constipation infants,” “constipation pregnancy,” “constipation elderly,” “constipation side effect,” “constipation medication,” and “constipation diagnosis.” 

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