ColitisPhase 1NCT04038619
Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients
A Phase 1 study testing Fecal Microbiota Transplantation and Loperamide in people with Colitis and Diarrhea, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis (inflammation of the intestines) that is caused by certain types of medications (called immune-checkpoint inhibitors) in patients with genitourinary cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Diarrhea, Malignant Genitourinary System Neoplasm
- What is being tested?
- Fecal Microbiota Transplantation and Loperamide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of any type of genitourinary (kidney, bladder and prostate), melanoma, non-melanoma skin cancer, lung, head \& neck, sarcoma/lymphoma, gastrointestinal system (luminal GI, hepatobiliary, pancreas), gynecology system (ovarian, uterine, cervical), and breast malignancies
- Treatment with any ICPI agent(s)
- Participants with new onset of ≥ grade 2 ICPI-induced diarrhea and/or colitis symptoms based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5 within 45 days prior to date of FMT treatment without involvement of non- GI toxicity
- Participants with a history of steroid use before FMT can be allowed if last dose was > 30 days prior to FMT treatment or treatment duration was for <7 days beyond one week prior to FMT treatment
- Participants with a history of immunosuppressant (Infliximab, Vedolizumab etc) use before FMT can be allowed if last dose was administered ≥ 3 months prior to FMT treatment when used for the treatment of conditions other than for ICI- induced GI toxicities (e.g., Infliximab is used in the treatment of Crohn's disease, rheumatoid arthritis, plaque psoriasis, and Vedolizumab is used in treating ulcerative colitis)
- No concern for active concomitant GI infection at the time of initiation of protocol therapy as confirmed by stool tests or as per the treating physician based on clinical presentation
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- Patient 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 protocol therapy and/ or imaging (e.g. CXR, CT CAP etc) confirms the absence of active infections (e.g. TB) within 60 days prior to initiation of protocol therapy
- Ability to understand and willingness to sign an informed consent form
- Life expectancy > 6 months
Who cannot join
- Age younger than 18 years
- Participants with persistent GI infection confirmed with positive stool test(s) despite completing 5 days of antibiotics prior to initiation of protocol therapy
- History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation
- Pregnant and breastfeeding women
- Women 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 participant is peri- or post-menopausal or there has been recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment
- Immunosuppressive treatment at onset of ICPI-induced diarrhea/colitis
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- Any medical conditions (e.g. severe heart failure, brain hemorrhage, septic shock, etc.) that are high risk for colonoscopy procedure by the assessment of the study PI or Co-PIs.
- Participants who develop concurrent non-GI toxicity at the time of study treatment
- Donors at risk for monkeypox infection and/ or exposure as determined by a questionnaire
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Yinghong Wang, 713-792-7672
Yinghong Wang
About this study
Official title: Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea/Colitis in Genitourinary Cancer Patients
This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis (inflammation of the intestines) that is caused by certain types of medications (called immune-checkpoint inhibitors) in patients with genitourinary cancer. Fecal microbiota transplantation may effectively reduce the incidence of immune checkpoint inhibitor-induced diarrhea/colitis.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the safety and tolerability of fecal microbiota transplantation (FMT).
- To assess the efficacy of FMT for clinical remission/response of immune-related diarrhea/colitis.
SECONDARY OBJECTIVES:
- To measure the recurrence rate after achieving clinical remission/response of immune-related diarrhea/colitis.
EXPLORATORY OBJECTIVES:
- To assess the efficacy of FMT to achieve endoscopic remission of immune-related diarrhea/colitis.
- To assess the efficacy of FMT to achieve histological remission of immune-related diarrhea/colitis.
- To assess the efficacy of FMT on recurrence of immune-related diarrhea/colitis after resumption of immune checkpoint inhibitors (ICPI).
- To assess immunological, molecular and microbiome changes in tissue/blood/stool.
To study the efficacy and/ or benefit of PuraStat gel in the healing of mucosal ulcers and its hemostatic effect on bleeding lesions
OUTLINE:
Patients receive loperamide orally (PO). After 4 hours, patients undergo FMT via colonoscopy over 15-30 minutes.
After completion of study treatment, patients are followed up at 2, 4, and 8 weeks, and then at 3 months.
- Conditions
- Colitis, Diarrhea, Malignant Genitourinary System Neoplasm, Melanoma, Lung Cancer, Ovarian Cancer
- Being tested
- Fecal Microbiota Transplantation, Loperamide
- Medical subject headings
- Colitis, Diarrhea, Urogenital Neoplasms, Melanoma, Lung Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationProcedure or surgery
Also called Fecal Material Transplantation, Fecal Transplantation, FMT, Poo Transplant
Undergo FMT via colonoscopy
LoperamideDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (loperamide, colonoscopy, FMT) | Experimental | Patients receive loperamide PO. After 4 hours, patients undergo FMT via colonoscopy over 15-30 minutes. Receives: Procedure: Fecal Microbiota Transplantation; Drug: Loperamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of fecal microbiota transplantation (FMT)-related adverse events
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5. All events are recorded with grade and attribution to FMT.
Measured: Up to 3 months post-FMT
Clinical response/remission of immune-related diarrhea/colitis
Clinical remission of immune related events defined as improvement of symptoms of grade 1 or lower within 2 weeks post-FMT. Clinical partial response of immune related diarrhea/colitis defined as improvement of diarrhea/colitis to a lower grade than the initial presentation but not meeting criteria of clinical remission at 2 week post-FMT time point.
Measured: At 2 weeks post-FMT
Secondary outcomes (1)
Recurrent immune-related diarrhea/colitis within 3 months post-FMT after initially achieving clinical remission/response
Recurrent immune-related diarrhea colitis events occurring post-FMT are recorded throughout the follow-up period.
Measured: Up to 3 months post-FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Feb 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColitisStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yinghong Wang, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038619
- Sponsor's protocol ID
- 2018-0663
- Other IDs
- NCI-2019-02660, 2018-0663
- Status last verified
- Sep 2026
- First submitted
- 26 Jul 2019
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wang Y, Fan C, Varatharajalu K, Shatila M, Cruz CC, Sun B, Lermi NO, Hayase T, Thomas A, Szymonowicz KA, Espiridion BS, Duose DY, Hayase E, Tan L, Liu Y, Chang CC, Arias CA, Junek K, DuPont HL, Jiang ZD, Kim ST, Nurieva R, Campbell MT, Tannir NM, Gao J, Watowich SS, Wang XS, Chen K, Lorenzi PL, Haymaker C, Parra ER, Jenq RR. First-line fecal microbiota transplantation for the management of immune checkpoint inhibitor-mediated diarrhea and colitis. Cell Rep Med. 2026 Sep 14:103044. doi: 10.1016/j.xcrm.2026.103044. Online ahead of print.
PubMed 42735684
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea/Colitis in Genitourinary Cancer Patients
- ClinicalTrials.gov ID
- NCT04038619
- Acronym / sponsor ID
- 2018-0663
- Conditions
- Colitis, Diarrhea, Malignant Genitourinary System Neoplasm, Melanoma, Lung Cancer, Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis (inflammation of the intestines) that is caused by certain types of medications (called immune-checkpoint inhibitors) in patients with genitourinary cancer. Fecal microbiota transplantation may effectively reduce the incidence of immune checkpoint inhibitor-induced diarrhea/colitis.
Detailed description
PRIMARY OBJECTIVES:
- To assess the safety and tolerability of fecal microbiota transplantation (FMT).
- To assess the efficacy of FMT for clinical remission/response of immune-related diarrhea/colitis.
SECONDARY OBJECTIVES:
- To measure the recurrence rate after achieving clinical remission/response of immune-related diarrhea/colitis.
EXPLORATORY OBJECTIVES:
- To assess the efficacy of FMT to achieve endoscopic remission of immune-related diarrhea/colitis.
- To assess the efficacy of FMT to achieve histological remission of immune-related diarrhea/colitis.
- To assess the efficacy of FMT on recurrence of immune-related diarrhea/colitis after resumption of immune checkpoint inhibitors (ICPI).
- To assess immunological, molecular and microbiome changes in tissue/blood/stool.
To study the efficacy and/ or benefit of PuraStat gel in the healing of mucosal ulcers and its hemostatic effect on bleeding lesions
OUTLINE:
Patients receive loperamide orally (PO). After 4 hours, patients undergo FMT via colonoscopy over 15-30 minutes.
After completion of study treatment, patients are followed up at 2, 4, and 8 weeks, and then at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (loperamide, colonoscopy, FMT) | Experimental | Procedure: Fecal Microbiota Transplantation, Drug: LoperamidePatients receive loperamide PO. After 4 hours, patients undergo FMT via colonoscopy over 15-30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of any type of genitourinary (kidney, bladder and prostate), melanoma, non-melanoma skin cancer, lung, head \& neck, sarcoma/lymphoma, gastrointestinal system (luminal GI, hepatobiliary, pancreas), gynecology system (ovarian, uterine, cervical), and breast malignancies
- Treatment with any ICPI agent(s)
- Participants with new onset of ≥ grade 2 ICPI-induced diarrhea and/or colitis symptoms based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5 within 45 days prior to date of FMT treatment without involvement of non- GI toxicity
- Participants with a history of steroid use before FMT can be allowed if last dose was > 30 days prior to FMT treatment or treatment duration was for <7 days beyond one week prior to FMT treatment
- Participants with a history of immunosuppressant (Infliximab, Vedolizumab etc) use before FMT can be allowed if last dose was administered ≥ 3 months prior to FMT treatment when used for the treatment of conditions other than for ICI- induced GI toxicities (e.g., Infliximab is used in the treatment of Crohn's disease, rheumatoid arthritis, plaque psoriasis, and Vedolizumab is used in treating ulcerative colitis)
Key exclusion criteria (9 listed)
- Age younger than 18 years
- Participants with persistent GI infection confirmed with positive stool test(s) despite completing 5 days of antibiotics prior to initiation of protocol therapy
- History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation
- Pregnant and breastfeeding women
- Women 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 participant is peri- or post-menopausal or there has been recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota TransplantationAlso: Fecal Material Transplantation, Fecal Transplantation, FMT, Poo TransplantUndergo FMT via colonoscopy | Procedure or surgery | Treatment (loperamide, colonoscopy, FMT) |
| LoperamideGiven PO | Drug | Treatment (loperamide, colonoscopy, FMT) |
Primary outcome
Incidence of fecal microbiota transplantation (FMT)-related adverse events
Time frame: Up to 3 months post-FMT
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5. All events are recorded with grade and attribution to FMT.
Clinical response/remission of immune-related diarrhea/colitis
Time frame: At 2 weeks post-FMT
Clinical remission of immune related events defined as improvement of symptoms of grade 1 or lower within 2 weeks post-FMT. Clinical partial response of immune related diarrhea/colitis defined as improvement of diarrhea/colitis to a lower grade than the initial presentation but not meeting criteria of clinical remission at 2 week post-FMT time point.
1 secondary outcome
Recurrent immune-related diarrhea/colitis within 3 months post-FMT after initially achieving clinical remission/response
Time frame: Up to 3 months post-FMT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Derived from this study: PubMed 42735684Wang Y, Fan C, Varatharajalu K, Shatila M, Cruz CC, Sun B, Lermi NO, Hayase T, Thomas A, Szymonowicz KA, Espiridion BS, Duose DY, Hayase E, Tan L, Liu Y, Chang CC, Arias CA, Junek K, DuPont HL, Jiang ZD, Kim ST, Nurieva R, Campbell MT, Tannir NM, Gao J, Watowich SS, Wang XS, Chen K, Lorenzi PL, Haymaker C, Parra ER, Jenq RR. First-line fecal microbiota transplantation for the management of immune checkpoint inhibitor-mediated diarrhea and colitis. Cell Rep Med. 2026 Sep 14:103044. doi: 10.1016/j.xcrm.2026.103044. Online ahead of print.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yinghong Wang principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fecal Microbiota Transplantation and Loperamide in people with Colitis and Diarrhea, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yinghong Wang (281-221-9138, ywang59@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of fecal microbiota transplantation (FMT)-related adverse events (time frame: Up to 3 months post-FMT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04038619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.