Recruiting

Stool transplant to treat severe diarrhea from cancer immunotherapy

Plain-English translation of NCT04038619 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated July 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

Some cancer patients taking immune-boosting medications called checkpoint inhibitors develop severe diarrhea or inflammation of the colon. This trial is testing fecal microbiota transplantation (FMT)—transferring healthy stool bacteria into your colon through a colonoscopy—to see if it can safely stop this diarrhea and help you feel better. Researchers want to learn whether this treatment works and what happens to your gut bacteria after the procedure.

Immune checkpoint inhibitor drugs are powerful cancer treatments, but they can trigger severe diarrhea in some patients, making treatment difficult to continue. This medication could restore the healthy bacteria in your gut and reduce these side effects, allowing patients to keep taking their cancer medicine.

Do you qualify?

You likely qualify if…

you have been diagnosed with cancer (including kidney, bladder, prostate, lung, skin, ovarian, uterine, cervical, breast, or other types) and are currently being treated with immune checkpoint inhibitor drugs
you have developed moderate to severe diarrhea or colon inflammation within the past 45 days as a side effect of your cancer medication
you are at least 18 years old and have a life expectancy of more than 6 months
you are willing to sign an informed consent form and understand what the study involves
you do not have an active gut infection confirmed by stool tests at the time of the procedure

You likely don't qualify if…

you are pregnant, breastfeeding, or could be pregnant
you have a history of inflammatory bowel disease like Crohn's disease or ulcerative colitis with active symptoms
you are currently taking strong immunosuppressant medications (like infliximab or vedolizumab) for your diarrhea
you have a persistent gut infection that did not improve after antibiotics
you have severe heart disease, brain bleeding, septic shock, or other serious medical conditions that make a colonoscopy procedure too risky for you

What participation looks like

You will take a medication called by mouth, then 4 hours later, you'll have a colonoscopy procedure where doctors transplant healthy stool bacteria into your colon—a procedure lasting 15–30 minutes. After that, you'll have follow-up visits at 2, 4, and 8 weeks, then again at 3 months so the doctors can check if your diarrhea has improved and monitor for any side effects. The research team will also collect blood and stool samples to study how the treatment changes your gut bacteria.

AI-generated summary from trial data · Jul 21, 2026 · Not medical advice

Trial locations(1 site)

United States

M D Anderson Cancer Center, Houston, Texas