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Could a poop transplant fix cancer treatment side effects?

NCT ID NCT03819296

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study looks at how the bacteria in your gut might cause stomach issues like diarrhea and colitis when you take certain cancer drugs called immune checkpoint inhibitors. Researchers will collect stool, blood, and tissue samples from 800 people with melanoma, lung cancer, or genitourinary cancers to understand these side effects. They will also test whether a fecal transplant (putting healthy donor stool into the patient) can help improve symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer or genitourinary (GU) malignancies (Project 1). 2. Diagnosis of any cancer type (Projects 2 and 3) 3. Treatment with any ICPI agent 4. Ability to understand and willingness to sign an informed consent form and rate surveys 5. Life expectancy \> 4 months (Project 3) 6. ICPI-related diarrhea and/or colitis of any grade with or without concurrent non- GI toxicity as the toxicity group (project 1) 7. Patients with no organ toxicity as the control group (project 1) 8. ICPI-related colitis and/or diarrhea of grade ≥ 2 as GI toxicity (initial episode or recurrence) receiving standard treatment of immunosuppressive agents (steroid, infliximab, vedolizumab, or ustekinumab) any time during the colitis disease course until sustained resolution of GI toxicity, or one- year time point after enrollment (Project 2) 9. ICPI-related colitis and/or diarrhea of grade ≥ 2 as GI toxicity without involvement of non- GI toxicity within 45 days prior to FMT (Project 3) 10. ICPI-related colitis and/or diarrhea of grade ≥ 2 within 45 days prior to FMT with ANY of the following characteristics (project 3): (i) refractory to treatment of steroid and two doses of non-steroidal immunosuppressants e.g. infliximab, vedolizumab or ustekinumab, (ii) contraindication for immunosuppressive treatment, (iii) recurrence after successful initial treatment, (iv) recurrent symptoms once steroid is tapered down/off or diarrhea/colitis symptoms are steroid dependent, or (v) patients with a history of refractory ICPI-related colitis and/or diarrhea to medical treatment, even if they have improved symptoms from supportive care within 45 days prior to FMT 11. No concern for active concomitant GI infection for the ICPI diarrhea/colitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation (project 3) 12. Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of diarrhea/colitis treatment (project 3) Exclusion Criteria: 1. Age younger than 18 years 2. History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation 3. Pregnant and breastfeeding women 4. Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \> 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment 5. Patients who develop concurrent non- GI toxicity at the time of FMT treatment (project 3) 6. Patients with active bacterial or fungal infection (Project 3) 7. Donors at risk for monkeypox infection and/ or exposure as determined by a questionnaire (Project 3) Withdrawal Criteria 1. Patients may withdraw from the trial at any time 2. Patients who develop GI perforation or toxic colitis that require surgery from ICPI colitis 3. In project 3, if the first 30% of cases fail the fecal transplant treatment, then project 3 will be terminated

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clinical stage 0 cutaneous melanoma ajcc V8 Clinical stage I cutaneous melanoma ajcc V8 Clinical stage IA cutaneous melanoma ajcc V8 Clinical stage IB cutaneous melanoma ajcc V8 Clinical stage II cutaneous melanoma ajcc V8 Clinical stage IIA cutaneous melanoma ajcc V8 Clinical stage IIB cutaneous melanoma ajcc V8 Clinical stage IIC cutaneous melanoma ajcc V8 Clinical stage III cutaneous melanoma ajcc V8 Clinical stage IV cutaneous melanoma ajcc V8 Colitis Lung non-small cell carcinoma Malignant genitourinary system neoplasm Malignant solid neoplasm Pathologic stage 0 cutaneous melanoma ajcc V8 Pathologic stage I cutaneous melanoma ajcc V8 Pathologic stage IA cutaneous melanoma ajcc V8 Pathologic stage IB cutaneous melanoma ajcc V8 Pathologic stage II cutaneous melanoma ajcc V8 Pathologic stage IIA cutaneous melanoma ajcc V8 Pathologic stage IIB cutaneous melanoma ajcc V8 Pathologic stage IIC cutaneous melanoma ajcc V8 Pathologic stage III cutaneous melanoma ajcc V8 Pathologic stage IIIA cutaneous melanoma ajcc V8 Pathologic stage IIIB cutaneous melanoma ajcc V8 Pathologic stage IIIC cutaneous melanoma ajcc V8 Pathologic stage iiid cutaneous melanoma ajcc V8 Pathologic stage IV cutaneous melanoma ajcc V8 Stage 0 lung cancer ajcc V8 Stage I lung cancer ajcc V8 Stage IA1 lung cancer ajcc V8 Stage IA2 lung cancer ajcc V8 Stage IA3 lung cancer ajcc V8 Stage IB lung cancer ajcc V8 Stage II lung cancer ajcc V8 Stage IIA lung cancer ajcc V8 Stage IIB lung cancer ajcc V8 Stage III lung cancer ajcc V8 Stage IIIA lung cancer ajcc V8 Stage IIIB lung cancer ajcc V8 Stage IIIC lung cancer ajcc V8 Stage IV lung cancer ajcc V8 Stage IVA lung cancer ajcc V8 Stage IVB lung cancer ajcc V8

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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