Clinical Trials for Crohn’s Disease

Medically Reviewed by Minesh Khatri, MD on June 30, 2022
4 min read

Clinical trials play an important role in the approval of new medications. It’s how researchers figure out if a drug works the way it’s supposed to. They also learn about potential side effects and other issues.

If you have Crohn’s disease, a clinical trial could give you access to a new drug before it’s available to everyone else. And sharing information about how the condition impacts you helps researchers develop future treatments. Find out what’s next on the horizon.

Medicines being tested to treat Crohn’s disease include:

Risankizumab (Skyrizi). This drug is approved to treat psoriasis and psoriatic arthritis. It affects how a protein known as interleukin-23 works. This protein is involved in your immune system response and is a factor in ongoing inflammation. Studies suggest it’s safe and effective to treat moderate to severe Crohn’s disease and keep it in remission.

Ozanimod (Zeposia). This drug is approved to treat another type of inflammatory bowel disease (IBD) known as ulcerative colitis. It targets sphingosine 1-phosphate (S1P) receptors, which stops immune cells from leaving lymph nodes and moving into the colon. This may ward off the inflammation seen in Crohn’s disease.

Upadacitinib (Rinvoq). This experimental drug works to block the action of enzymes known as Janus kinases, which trigger inflammation. This may help bring inflammation in the gut under control. In one small study, upadacitinib led to remission in up to 27% of participants on a certain dosage.

It’s not clear why some people get Crohn’s disease while others don’t. Some of it may be genetic. But another component may be environmental. That’s why there are clinical trials to examine factors thought to play a role in IBD, like diet, stress, viruses, and smoking. They include:

Diet. Past research has found that a Mediterranean-style diet or the specific carbohydrate diet, which limits grains and dairy, can both improve symptoms of Crohn’s disease. Now, researchers at Stanford are studying whether an intermittent calorie-reduced diet (ICRD) that mimics fasting affects inflammation in people with mild to moderate Crohn's disease. Other research is looking at whether removing certain things from the diet, such as processed food or soy, can help.

Stress. It’s thought that stress impacts Crohn’s disease, but there’s little research on whether it may actually worsen symptoms and flare-ups. Researchers are now exploring whether digital tools like smartphones and wearable devices can help figure out new information such as increased stress levels that can cause fluctuations in symptoms.

Pediatric clinical trials are especially important because almost half of all medicines prescribed to children are never actually tested in a clinical trial. Here’s what we found:

CAPTURE IBD (Cohort for Pediatric Clinical and Translational Research in IBD). The aim is to build a database of information on kids aged 4-21 with inflammatory bowel diseases. Enrolled kids get their usual care, but they also provide blood, stool, and tissue samples to researchers. The samples are analyzed to look for certain signs that may mean you’re more likely to respond to a certain drug. The hope is that doctors will one day be able to match children to the specific medications most effective for them.

Fecal transplants. This is when stool from a healthy person is transplanted into someone else. Research shows that the gut microbiome, or gut bacteria, of kids with Crohn’s disease is different from those without the condition. Doctors are now studying whether a fecal transplant can help by providing them with new bacteria from a healthier microbiome.

Surgery. Some people with Crohn’s disease also need surgery to manage their disease. The IBD SIRQC (Surgical Innovation, Research, and Quality Collaborative) is a surgical research initiative that follows adults with Crohn’s disease through their surgery and beyond to track their long-term surgery outcomes. The hope is that they will gain a better understanding of the impact of surgery on IBD coming back. It can also help doctors figure out who’s more likely to stay healthy after surgery and who will need more treatment.

Treat-to-target. It’s also not clear how to treat people who have Crohn’s disease but no symptoms. Their gut is still damaged. Researchers at the University of California San Diego and Baylor College of Medicine will study whether aggressively treating intestinal inflammation in people without symptoms helps or hurts. Participants will either continue to follow their current treatment plan or will switch medication with the goal of healing GI inflammation.

Stem cell treatments. Some people with Crohn’s disease don't get help from any clinical treatments, or only find temporary benefit. Stem cell therapy may be a viable option. An experimental treatment called “high-dose immunoablation” followed by stem cell transplant shows promise. The idea is doctors will be able to reset a patient’s immune system to what it was before Crohn’s disease took hold.

There are several ways you can get information about clinical trials for Crohn’s disease:

  • Talk to your doctor or health care provider.
  • Search
  • The Crohn’s and Colitis Foundation has a clinical trial finder here that allows you to search for trials in your area.

Once you find a clinical trial that you want to join, contact the study coordinator. They will arrange for you to be screened by staff to make sure you are a good fit. Don’t be discouraged if you’re not accepted. Different trials have different needs. You may be a good fit for another one.