Inflammatory Bowel Disease (Ulcerative Colitis and Crohn’s Disease)

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Inflammatory Bowel Disease ( Ulcerative Colitis and Crohn’s Disease)

General Purpose:

Inflammatory bowel disease, or IBD, refers to chronic inflammation of all or a part of the digestive tract. It generally describes two separate conditions, including ulcerative colitis and Crohn’s disease.

Ulcerative colitis is a long-term inflammation of the innermost lining of the large intestine (or colon) and the rectum. It typically affects one, single continuous section of the colon and rectum. Crohn’s disease, on the other hand, can occur anywhere in the intestines, and unlike ulcerative colitis, can affect separate segments of tissue simultaneously or at different times.

The causes of ulcerative colitis and Crohn’s disease are not known. Although stress was once believed to be a causal factor, most researchers now believe that a combination of genetic factors and immune system dysfunction is likely the primary cause. Stress can, however, aggravate symptoms of both conditions.

Risk factors for ulcerative colitis and Crohn’s disease are very similar and include the following: age under 30; Caucasian race, in particular Ashkenazi Jewish descent; and family history of inflammatory bowel disease.

In addition, some research suggests that prior use of the drug Accutane (now known as Amnesteem, Claravis, and Sotret), which was used to treat cystic acne, may also increase the risk of developing inflammatory bowel disease.

With specific regard to Crohn’s disease, cigarette smoking is the most important preventable risk factor; smoking can also lead to the development of more severe disease and a greater likelihood of requiring surgery. 

Individuals who live in urban areas or industrialized are also more likely to develop Crohn’s disease, as are those who live in northern climates.

Both ulcerative colitis and Crohn’s disease can result in extreme pain, debilitation, and life-threatening complications, including intestinal blockages, ulcers, fistulas (abnormal passages between the intestines and skin, or the intestines and other organs, such as the bladder and vagina), and malnutrition.

Both conditions also increase the risk of developing osteoporosis and colon cancer. More specifically, Crohn’s disease can lead to diarrhea, blood in the stool, abdominal cramping, and weight loss.

In severe cases, it can cause arthritis, eye inflammation, mouth sores, skin disorders, and delayed growth in children. Usually, the signs and symptoms associated with Crohn’s disease can range from mild to severe, and periods of remission (total absence of symptoms) are common.

On the other hand, ulcerative colitis is usually classified according to where it is located within the colon, and symptoms vary according to location. Rectal bleeding or pain, bloody diarrhea, constipation, and severe weight loss can occur.

 Fulminant colitis (a condition in which ulcerative colitis affects the entire length of the colon) can lead to profuse diarrhea, dehydration, and shock. This condition can be life-threatening and requires immediate medical attention. Although ulcerative colitis can go through periods of remission, the severity of disease tends to remain constant.

Considerable research is underway to develop new and more effective treatments for all forms of inflammatory bowel disease, as well as improving methods of diagnosing and classifying it. Scientists are also working to gain a better understanding of how the digestive system works as a whole, and to learn how environmental and genetic factors influence the development of inflammatory bowel disease.

What Will Inflammatory Bowel Disease Clinical Trials Be Like?

The types of tests and assessments used in clinical trials for inflammatory bowel disease will ultimately depend on the specific nature of the study and which particular condition is being evaluated. Provided below is a list of frequent procedures and tests that may be incorporated into clinical trials:

  • Physical exam and detailed medical history
  • Blood tests to look for signs of anemia or infection
  • Blood and/or tissue sample for the purposes of conducting genetic testing
  • If the study is evaluating a new type of medication or vaccine, blood and/or urine tests may be performed to monitor how your body metabolizes the medication or how effectively your body has responded to the vaccine.
  • Food diary to track dietary intake over an extended period of time.
  • Fecal occult blood test (FOBT) to check for hidden blood in fecal matter.
  • Sigmoidoscopy, which is a procedure during which the rectum and lower colon are examined using a thin, flexible tube with a tiny light and camera on the end.
  • Colonoscopy, which is a procedure similar to a sigmoidoscopy, however it is used to view the entire colon.
  • Double contrast barium enema (DCBE). This procedure involves taking a series of x-rays after the patient is given a barium-containing enema and air is introduced into the colon to make it more visible.
  • Imaging procedures such computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans. These imaging procedures are non-invasive and provide detailed pictures of areas inside your body.  
  • X-ray
  • Biopsy
  • 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 Inflammatory Bowel Disease Clinical Trial Protocol:

Specific examples of clinical trials for inflammatory bowel disease might include the following:

  • An interventional study to determine if girls and women between the ages of 9 and 26 – all of whom have ulcerative colitis or Crohn’s disease – have a favorable immune response to the vaccine designed to prevent the transmission of human papillomavirus (HPV). The purpose of this study would be to determine if the immune system of these women with IBD impairs their body’s ability to respond appropriately to the vaccine.
  • An observational study in which participants with ulcerative colitis, Crohn’s disease, and healthy volunteers all provide blood and tissue samples for the purposes of genetic testing. The goal of such a study would be to evaluate the tissue of individuals with and without inflammatory bowel disease to identify genes that are potentially associated with an increased risk of inflammatory bowel disease.
  • A randomized clinical trial to determine the safety and efficacy of an investigational drug as treatment for Crohn’s disease and ulcerative colitis. In this study, half of the patients would be randomly assigned to receive treatment with the new drug while the other half would receive 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.

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 third 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 personal diagnosis of inflammatory bowel disease. This would include Crohn’s disease, or your specific sub-type of ulcerative colitis, if known. The distinct subtypes of ulcerative colitis include the following:
    • Ulcerative proctitis
    • Proctosigmoiditis
    • Left-sided colitis
    • Pancolitis
    • Fulminant colitis
    • Any underlying illnesses you have
    • Your current medications (including aspirin), vitamins, and dietary supplements
    • Your history of treatment for inflammatory bowel disease

Suggested Search Terms:

Once you are ready to begin your search for clinical trials of interest, the following terms may be of use when combined with your particular diagnosis of inflammatory bowel disease: “prevention,” “management,” “treatment,” “diet,” “exercise,” “disease,” “elderly,” “pediatric,” “side effects,” “medication,” “surgery,” and “diagnosis.” 

Current Search Term:

“Inflammatory Bowel Disease ( Ulcerative Colitis and Crohn’s Disease)”

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Corrona Inflammatory Bowel Disease (IBD) Registry

Condition:   Inflammatory Bowel Diseases
Sponsor:   Corrona, LLC.
Enrolling by invitation - verified May 2017

Intestinal Mesenchymal Stem Stells and Inflammatory Bowel Diseases

Condition:   Inflammatory Bowel Diseases
Interventions:   Other: Intestinal biopsies during colonoscopy;   Other: Biopsies taken on surgical specimen
Sponsor:   University Hospital, Montpellier
Not yet recruiting - verified April 2017

Intestinal Ultrasound in Pediatric Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Diseases
Intervention:   Device: Intestinal ultra-sound monitoring
Sponsor:   Schneider Children's Medical Center, Israel
Not yet recruiting - verified April 2017

Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells in Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Diseases
Interventions:   Procedure: Lipoaspiration;   Procedure: AD-cSVF;   Procedure: Normal Saline IV
Sponsors:   Healeon Medical Inc;   Glenn Terry, MD
Recruiting - verified March 2017

Electronic Linkage for Inflammatory Bowel Disease to Deliver Joint Access to Health Reports

Condition:   Inflammatory Bowel Diseases
Intervention:   Other: Health reports
Sponsors:   Phedra Dodds;   Swansea University;   The Health Foundation
Completed - verified December 2016

A Retrospective Observational Study to Assess the Impact of Co-morbidities on Treatment Response in Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Disease
Intervention:   Other: No Intervention
Sponsor:   Takeda
Recruiting - verified May 2017

The Altitude Inflammatory Bowel Disease Study

Condition:   Inflammatory Bowel Disease
Interventions:   Other: hypobaric pressure chamber;   Other: Sigmoidoscopy
Sponsors:   University of Zurich;   Triemli Hospital;   Zurich Center for Integrative Human Physiology;   Institute of Biostatistics;   University Hospital Inselspital, Berne;   Institute of Physiology Irchel;   Institute of Veterinary Physiology;   Swiss Aeromedical Center Switzerland;   Institute of Experimental Immunology;   Institute of Pathology, University Hospital Zurich
Active, not recruiting - verified July 2016

A Study on the Effectiveness of a Nutritional Supplement With Natural Mastiha in Inflammatory Bowel Diseases.

Condition:   Inflammatory Bowel Diseases
Interventions:   Dietary Supplement: Mastiha;   Dietary Supplement: Placebo
Sponsor:   Harokopio University
Recruiting - verified May 2017

Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Disease
Intervention:   Biological: sampling
Sponsor:   Assistance Publique - Hôpitaux de Paris
Recruiting - verified June 2016

An Efficacy and Safety Study of Infliximab in Pediatric Participants With Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Diseases
Intervention:   Drug: Infliximab
Sponsor:   Janssen Scientific Affairs, LLC
Recruiting - verified May 2017

Effects of Exclusive Enteral Nutrition on the Microbiome in Pediatric Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Diseases
Interventions:   Dietary Supplement: Exclusive Enteral Nutrition (EEN);   Drug: Prednisone
Sponsors:   McMaster Children's Hospital;   Canadian Association of Gastroenterology
Completed - verified April 2017

Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2008).

Condition:   Pediatric Inflammatory Bowel Disease
Sponsor:   Centre Hospitalier Universitaire, Amiens
Recruiting - verified January 2017

Fecal Transplantation for Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Disease
Intervention:   Biological: Fecal microbial l transplantation
Sponsor:   Meir Medical Center
Terminated - verified June 2016

Acceptance and Commitment Therapy (ACT) in Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Disease
Intervention:   Behavioral: Acceptance and Committment Therapy (ACT)
Sponsor:   University College Dublin
Completed - verified May 2017

Inflammatory Bowel Disease Registry in Daegu-Gyeongbuk

Condition:   Idiopathic Chronic Inflammatory Bowel Disease
Sponsors:   Kyungpook National University;   Yeungnam University Hospital;   Daegu Catholic University Medical Center;   DongGuk University
Recruiting - verified July 2016

Integrated Care for Inflammatory Bowel Disease Patients in the Netherlands With the Novel Telemedicine Tool myIBDcoach: a Randomized Controlled Trial

Condition:   Inflammatory Bowel Disease
Interventions:   Other: myIBDcoach;   Other: Standard care
Sponsor:   Maastricht University Medical Center
Completed - verified September 2016

Long-term Functional Outcome of Children With Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Disease
Sponsor:   University of Manitoba
Completed - verified October 2016

Safety and Tolerability Of Allogeneic Mesenchymal Stromal Cells in Pediatric Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Diseases
Intervention:   Biological: Allogeneic bone marrow-derived mesenchymal stromal cells
Sponsor:   Catherine Bollard
Recruiting - verified October 2016

Steroid-induced Mood Changes in Patients With Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Disease 11
Intervention:   Drug: Prednisone
Sponsor:   University of British Columbia
Completed - verified October 2016

Bone Marrow Stromal Cells for Inflammatory Bowel Diseases

Condition:   Inflammatory Bowel Disease
Intervention:   Other: Bone Marrow Stromal Cell (BMSC) Infusion
Sponsor:   National Institute of Allergy and Infectious Diseases (NIAID)
Active, not recruiting - verified February 28, 2017

Diet and Disease Activity in Patients With Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Disease
Sponsors:   Maastricht University Medical Center;   Wageningen University
Recruiting - verified December 2016

Gut Microbiota in the Healthy Population, Inflammatory Bowel Disease Patients, and Their Relatives

Condition:   Inflammatory Bowel Disease
Sponsor:   Chinese University of Hong Kong
Active, not recruiting - verified April 2017

Telomere Repair Gene Mutation in Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Disease
Sponsor:   National Heart, Lung, and Blood Institute (NHLBI)
Completed - verified June 15, 2016

Genetic Studies of Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Disease
Sponsor:   National Human Genome Research Institute (NHGRI)
Completed - verified September 19, 2007

Collection of Specimens for Study of Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Diseases
Sponsor:   National Institute of Allergy and Infectious Diseases (NIAID)
Completed - verified January 8, 2010

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