Constipation

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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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“Constipation”

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Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation


Condition:   Chronic Constipation in Diabetic Patients
Intervention:   Drug: linaclotide or placebo
Sponsor:   Texas Tech University Health Sciences Center, El Paso
Active, not recruiting - verified May 2017


ISE to Support Constipation Management


Condition:   Constipation
Interventions:   Other: Educational practice for HCPs,Dissemination only;   Other: Educational practice for HCPs,Spaced Education
Sponsor:   Children's Hospital Medical Center, Cincinnati
Recruiting - verified November 2016


General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation


Condition:   Chronic Constipation
Intervention:   Drug: AJG555
Sponsor:   EA Pharma Co., Ltd.
Active, not recruiting - verified May 2017


Transabdominal Electrical Stimulation for Constipation


Condition:   Constipation
Interventions:   Device: Interferential Stimulation;   Device: TENS stimulation
Sponsor:   St Mark's Hospital Foundation
Completed - verified October 2016


A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation


Condition:   Chronic Constipation
Interventions:   Drug: ASP0456;   Drug: Placebo
Sponsor:   Astellas Pharma Inc
Active, not recruiting - verified April 2017


Clinical Trial on Palliative Cancer Patients With Constipation


Condition:   Constipation
Interventions:   Drug: Chinese herbal medicine;   Drug: Placebo
Sponsors:   Hong Kong Baptist University;   Caritas Medical Centre;   Yan Chai Hospital;   Hospital Authority, Hong Kong
Recruiting - verified December 2016


Colonic Motility in Constipation and Aging: A Study With a New 3D Transit System


Condition:   Constipation
Intervention:   Device: MTS2
Sponsor:   University of Aarhus
Not yet recruiting - verified April 2016


Naloxegol in Cancer Opioid-Induced Constipation


Condition:   Constipation
Intervention:   Drug: naloxegol
Sponsors:   University of California, San Diego;   AstraZeneca
Recruiting - verified February 2017


Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women


Condition:   Functional Constipation
Interventions:   Dietary Supplement: Lactobacillus gasseri DSM 27123;   Dietary Supplement: Placebo
Sponsor:   BioGaia AB
Completed - verified September 2016


A Study Investigating the Effect of Digesta-Lac in Healthy Adults With Occasional Constipation


Condition:   Occasional Constipation
Interventions:   Dietary Supplement: Digesta Lac;   Other: Placebo
Sponsors:   KGK Synergize Inc.;   Global Institute of Probiotics
Completed - verified June 2016


Phase II Study of KWA-0711 in Patients With Chronic Constipation (CC)


Condition:   Chronic Constipation
Intervention:   Drug: KWA-0711
Sponsor:   Kissei Pharmaceutical Co., Ltd.
Completed - verified May 2017


Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)


Condition:   Chronic Constipation
Interventions:   Drug: KWA-0711;   Drug: Placebo
Sponsor:   Kissei Pharmaceutical Co., Ltd.
Completed - verified May 2017


Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation


Condition:   Constipation
Interventions:   Drug: Prucalopride;   Drug: Polyethylene glycol (PEG);   Drug: Lactulose
Sponsor:   Xian-Janssen Pharmaceutical Ltd.
Completed - verified November 2016


Study to Evaluate the Effects of RM-131 in Patients With Chronic Constipation


Condition:   Chronic Constipation
Interventions:   Drug: RM-131;   Drug: Placebo
Sponsors:   Motus Therapeutics, Inc.;   Mayo Clinic
Completed - verified September 2016


MRI and Microbiota Analysis in Constipation


Condition:   Constipation
Interventions:   Dietary Supplement: Ispaghula;   Dietary Supplement: Maltodextrin
Sponsors:   University of Nottingham;   Ironwood Pharmaceuticals, Inc.
Completed - verified January 2017


Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial


Condition:   Constipation
Interventions:   Procedure: acupuncture;   Drug: Prucalopride
Sponsors:   Guang'anmen Hospital of China Academy of Chinese Medical Sciences;   Ministry of Science and Technology of the People´s Republic of China
Completed - verified October 2016


A Trial of Three Types of Enemas Used to Treat Functional Constipation in Children


Condition:   Functional Constipation
Interventions:   Drug: Sodium phosphate enema;   Drug: Normal saline enema;   Drug: Mineral oil enema
Sponsor:   Children's Hospital Los Angeles
Suspended - verified January 2017


Phase 2 Study to Evaluate Safety and Efficacy of RM-131 Administered to Patients With Chronic Constipation


Condition:   Constipation
Interventions:   Drug: RM-131;   Drug: Placebo
Sponsor:   Motus Therapeutics, Inc.
Completed - verified September 2016


Methylnaltrexone for Opioid Induced Constipation


Condition:   Constipation
Intervention:   Drug: methylnaltrexone
Sponsors:   VU University Medical Center;   Fonds Nuts Ohra
Terminated - verified March 2017


Maintenance Treatment for Children With Constipation


Condition:   Constipation
Interventions:   Drug: Polyethylene glycol 3350;   Other: Placebo
Sponsors:   Line Modin;   University of Southern Denmark;   Kolding Sygehus
Completed - verified August 2016


Modified Functional Magnetic Stimulation Treatment for Constipation Improvement


Condition:   Constipation
Intervention:  
Sponsor:   Taipei Medical University WanFang Hospital
Withdrawn - verified November 2016


Managing Medication-induced Constipation in Cancer: A Clinical Trial


Condition:   Constipation
Interventions:   Other: Laxative Treatment;   Other: Standard of Care;   Other: Assessment Questionnaires
Sponsors:   H. Lee Moffitt Cancer Center and Research Institute;   National Institutes of Health (NIH);   University of South Florida
Completed - verified March 2015


Glucomannan for Childhood Functional Constipation.


Condition:   Functional Constipation
Interventions:   Dietary Supplement: Glucomannan;   Dietary Supplement: maltodextrin
Sponsor:   Medical University of Warsaw
Completed - verified February 2017


An Efficacy and Safety Study of Prucalopride in Participants With Chronic Constipation


Condition:   Constipation
Interventions:   Drug: Prucalopride;   Drug: Placebo
Sponsor:   Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Completed - verified March 2017


Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation


Conditions:   Constipation;   Chronic Constipation
Intervention:   Drug: A3309
Sponsor:   Albireo
Completed - verified February 2017

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