Fecal Microbial Transplants for the Treatment of Pancreatic Cancer
Reason given: PI request
Key facts
- Where
- Houston, United StatesSee the site
- Phase
- Early phase 1
Where in United States
- M D Anderson Cancer CenterHouston, United StatesNo longer taking part
Trial details
- Who runs it
- M.D. Anderson Cancer Center
- Trial code
- NCT04975217
- Record updated
- 10 November 2026
- Original description
This early phase I trial examines the safety and effects of fecal microbial transplants in treating patients with pancreatic cancer. scheduled for surgery to remove tumors. Fecal microbial transplant contains the normal microbes found in fecal (stool) material. Giving fecal microbial transplant may help control the disease.Read full original descriptionShow less
Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer
This early phase I trial examines the safety and effects of fecal microbial transplants in treating patients with pancreatic cancer. scheduled for surgery to remove tumors. Fecal microbial transplant contains the normal microbes found in fecal (stool) material. Giving fecal microbial transplant may help control the disease.
Inclusion: Patients that are seen at MD Anderson Cancer Center; Patients with pancreatic ductal adenocarcinoma (PDAC) diagnosis who are expected to have surgery (Whipple); Adequate hematological function, defined by white blood cell (WBC) count ≥ 3,000/microL, platelet count ≥75,000/microL, and Hgb ≥ 8 g/dL; Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN), an AST, level ≤ 2.5 × ULN, and an ALT level ≤ 2.5 × ULN; Adequate renal function defined by an estimated creatinine clearance >30 mL/min according to the Cockcroft-Gault formula or by a creatinine clearance measurement from a 24-hour urine collection; Age 18 years and above; Male or female; Willingness and ability to sign an informed consent; Consent and ability to give blood and stool samples; Consent to undergo a baseline core biopsy and colonoscopy for FMT delivery; An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Exclusion: Patient received antibiotics in the last 48 hours. Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to start of study; Positive GI infection; Patients with pancreatic cancer Stage T1N0; Patients with active viral, bacterial or fungal infection; History of inflammatory bowel disease, and/or radiation enteritis or colitis; History of intestinal obstruction; Acute exacerbation of underlying comorbid condition; Allergies to drugs included as part of trial (antibiotics, loperamide or laxatives); Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test; Peripheral WBC >12 x 10\^9/L and/or temperature >38 degrees Celsius; Subjects with neutropenia (ANC <1500); Age younger than 18 years; Individuals at higher risk of colonization with MDROs; Pregnant and breastfeeding women; Has a diagnosis of immunodeficiency; Swallowing dysfunction or known chronic aspiration; Delayed gastric emptying; Severely immunocompromised patients.