Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer

Trial ID: NCT04975217

Interventional - Phase 1 - Suspended

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.

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

• Fecal Microbiota Transplantation
• Fecal Microbiota Transplantation Capsule
• Questionnaire Administration
• Resection
• Therapeutic Colonoscopy

Eligibility

Inclusion criteria

• 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 criteria

• Age younger than 18 years
• Positive GI infection
• Patients with pancreatic cancer Stage T1N0
• Individuals at higher risk of colonization with MDROs
• 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
• Patients with active viral, bacterial or fungal infection
• History of inflammatory bowel disease, and/or radiation enteritis or colitis
• Pregnant and breastfeeding women
• Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test
• Has a diagnosis of immunodeficiency
• Peripheral WBC \>12 x 10\^9/L and/or temperature \>38 degrees Celsius
• Subjects with neutropenia (ANC \<1500)
• Swallowing dysfunction or known chronic aspiration
• Delayed gastric emptying
• History of intestinal obstruction
• Acute exacerbation of underlying comorbid condition
• Severely immunocompromised patients
• Allergies to drugs included as part of trial (antibiotics, loperamide or laxatives)

Sponsor

M.D. Anderson Cancer Center

Source: ClinicalTrials.gov

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