For Crohn’s disease and ulcerative colitis clinical trials, participants may need to visit the study doctor more often than they would for normal care. During the clinical trial, there are different types of assessments. These may include:
Physical exams
- In these exams the study doctor may focus on areas that can be affected by Crohn’s disease or ulcerative colitis. They may check your eyes for inflammation, look into your mouth for sores, and feel for lymph nodes in your neck and underarms.
- They may also look at your skin to see if you have any signs of skin involvement, and check if your abdomen (belly) is tender by gently pressing on the area. They will also check the skin around the anus as this can be affected by Crohn’s disease. They will also usually listen to your heart and lungs.
Lab tests and other assessments
A chest x-ray
- This may be done to look for signs of infection or fibrosis (lung scarring).
An ECG (electrocardiogram)
- This is also known as an EKG. It is a painless procedure that looks at the electrical activity of your heart.
Blood samples
- To check for infections, your blood count, how organs like your liver and kidneys are working, and if you are pregnant.
- While on the study, the study team may collect blood samples to see how your body is processing the study medicine and to ensure it is safe for you.
Other measurements
- Weight, height and vital signs such as your temperature, heart rate and blood pressure are also recorded.
Stool tests play an important role in clinical research studies for inflammatory bowel diseases. They may be self-collected by the participant at home, using a kit supplied by the study team. Or they may be collected at the research center. The study team will fully explain how to collect the stool sample and how and when to return it for analysis.
After the sample is collected it will be analyzed at the laboratory. This is usually done to check for clostridium difficile (“C.diff”) infection and other infections. It can also be used to check for markers of intestinal inflammation such as fecal calprotectin.
Endoscopy or Colonoscopy
Endoscopy is a procedure performed by a healthcare professional, this may be a doctor or surgeon. During endoscopy a camera is used to look at different parts of the digestive system. There are different types of endoscopy and the type used depends on the area of the digestive tract that needs to be assessed. In Crohn’s disease and ulcerative colitis clinical research studies colonoscopy and flexible sigmoidoscopy are often used.
A colonoscopy is when the flexible tube is inserted via the anus. This so done so that the inside of the rectum and the entire colon (large intestine), as well as the end of the small intestine can be seen.
In flexible sigmoidoscopy the flexible tube is also inserted via the anus. However, in this procedure, a limited part of the colon (large intestine) is seen. It is just the rectum and lower colon, also known as the “sigmoid colon” or “descending colon” that is examined.
In both procedures biopsies (tissue samples) can be collected. They are usually done during the screening period of the study to determine how severe your condition is. During the study, the tissue sample can be looked at to assess the safety and effectiveness of the study medicine. The tissue can also be used to look for signs of infection, inflammation, and cancer.
Preparation for endoscopy is key.
Full instructions will be provided by the study team at your research site, and you will have the opportunity to ask questions and raise any concerns with them.
As part of the preparation, you may need to drink a laxative solution that clears your bowel before the procedure. You will need to have easy access to a toilet during the preparation as you may need to use it often.
The study team at your research site will provide specific details about fasting requirements before the procedure.
Once the procedure is over, you will usually need to have a trusted friend or family member to drive you home and stay with you as you recover from the procedure.
Patient Reported Outcome (PRO) Questionnaires
Crohn’s disease and ulcerative colitis can have far reaching impacts on a person's social and emotional wellbeing and quality of life. An important part of clinical research studies is to assess the impact the condition is having on these different areas. This is usually done by completing questionnaires designed for this purpose. Participants may also need to complete a study diary to record symptoms, including how often you pass a stool and what the stool is like.
Diverse Representation
Participant Wellbeing
Impact and Results
