Receive a gut bacteria transplant and try a modified diet for active Crohn's disease

What is this trial?

This trial is testing whether adding a fecal microbiota transplant (a procedure where healthy gut bacteria from a donor are placed into your colon) and a special Crohn's disease exclusion diet can work better than the medication alone to control your Crohn's disease. You would receive the transplant several times over the study period and follow dietary guidance, while continuing your regular advanced Crohn's medication. The goal is to help people whose disease isn't fully controlled by medication alone.

Many people with active Crohn's disease don't get complete relief even with the strongest available medications—doctors call this 'hitting a ceiling.' Researchers believe that restoring healthy gut bacteria and removing foods that trigger inflammation might help the medication work better and give patients better control of their disease.

Do you qualify?

You likely qualify if…

you have been diagnosed with active Crohn's disease that needs treatment
you are between 18 and 75 years old
your disease is moderate to severe, or you haven't responded well to standard treatments
you are willing to receive a transplant procedure via colonoscopy and follow dietary guidance
you have not had Crohn's surgery in the past

You likely don't qualify if…

you are currently in remission (your Crohn's disease is well-controlled and inactive)
you have severe strictures (narrowing) in your bowel that cannot be passed
you have fistulas or abscesses related to your Crohn's disease
you have active tuberculosis, sepsis, or untreated infections
you are pregnant, breastfeeding, or have serious heart, liver, or kidney disease

What participation looks like

You would visit the clinic multiple times over about one year. In the first 6 weeks, you would receive transplant procedures (or a sham procedure with sterile water) via colonoscopy at weeks 0, 2, and 6. If your disease improves, you would continue receiving treatments every 8 weeks through week 42. You would also follow either a special diet that eliminates certain inflammatory foods, or receive general dietary counseling, depending on which group you're assigned to. Throughout the study, you would continue taking your regular advanced Crohn's medication and have your disease monitored through clinic visits and blood tests.

Gut bacteria transplant and special diet to improve Crohn's disease control

What is this trial?

Do you qualify?

What participation looks like

Trial locations(6 sites)