Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
Public ClinicalTrials.gov record NCT03819296. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Role of Microbiome in the Realm of Immune-Checkpoint Inhibitor Induced GI Complications In Cancer Population
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial studies the role of the gut microbiome and effectiveness of a fecal transplant on medication-induced gastrointestinal (GI) complications in patients with melanoma or genitourinary cancer. The gut microbiome (the bacteria and microorganisms that live in the digestive system) may affect whether or not someone develops colitis (inflammation of the intestines) during cancer treatment with immune-checkpoint inhibitor drugs. Studying samples of stool, blood, and tissue from patients with melanoma or genitourinary cancer may help doctors learn more about the effects of treatment on cells, and help doctors understand how well patients respond to treatment. Treatment with fecal transplantation may help to improve diarrhea and colitis symptoms.
Study identification
- NCT ID
- NCT03819296
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 800 participants
Conditions and interventions
Conditions
- 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
Interventions
- Best Practice Other
- Biospecimen Collection Other
- Endoscopic Procedure Procedure
- Fecal Microbiota Transplantation Procedure
- Infliximab Biological
- Laboratory Biomarker Analysis Other
- Prednisone Drug
- Vedolizumab Biological
Other · Procedure · Biological + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 20, 2021
- Primary completion
- Oct 30, 2026
- Completion
- Oct 30, 2026
- Last update posted
- Jul 14, 2026
2021 – 2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03819296, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03819296 live on ClinicalTrials.gov.