Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Study Overview

Study Details

Study overview

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.

Pilot Study Using Fecal Microbial Transplants in Patients with Pancreatic Cancer

Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

Condition
Pancreatic Ductal Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Florencia McAllister, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2026-12-31