Receive fecal transplant and try a special diet for ulcerative colitis

Recruiting

What is this trial?

This trial is testing whether fecal microbiota transplantation (FMT)—a procedure where healthy stool from a donor is placed in your colon—combined with an anti-inflammatory diet can help treat newly diagnosed ulcerative colitis. All participants also receive 5-aminosalicylic acid, a standard medication for this condition. The study wants to see if these newer approaches, either alone or together, work better than the medication alone.

Ulcerative colitis is a serious bowel condition that causes ongoing inflammation and symptoms. While the medication used here helps some patients, researchers believe that changing the bacteria in your gut (the microbiome) through transplant and diet modifications might offer additional benefits and help more people achieve long-lasting relief.

Do you qualify?

You likely qualify if…

you have been newly diagnosed with ulcerative colitis that has not been treated before
your disease is mild to moderate (not severe)
you are between 18 and 75 years old
you are willing to receive the fecal transplant procedure
you agree to follow a specific diet for the duration of the study

You likely don't qualify if…

you have severe ulcerative colitis or signs of a medical emergency related to your colon
you have a different type of colitis or inflammatory bowel disease
you are pregnant or breastfeeding
you have a current infection in your stool or a positive test for certain harmful bacteria
you have serious problems with your kidneys, liver, heart, lungs, or other major organs

What participation looks like

You will be randomly assigned to one of four groups: some will receive the fecal transplant procedure plus a special diet, some will receive the transplant with a standard diet, some will receive the special diet alone, and some will receive standard care only (all groups also take the medication). If you receive the transplant, you'll have three procedures during the first 6 weeks, then additional treatments over the next 9 months if your disease improves. You'll also receive dietary guidance and use a mobile app to track your eating. The study lasts 48 weeks total, and you'll have regular follow-up visits to check how you're doing.

Fecal transplant and special diet for newly diagnosed ulcerative colitis

What is this trial?

Do you qualify?

What participation looks like

Trial locations(6 sites)