Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT04975217

Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

Led by M.D. Anderson Cancer Center · Updated on 2026-03-20

10

Participants Needed

1

Research Sites

263 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients seen at MD Anderson Cancer Center
  • Diagnosed with pancreatic ductal adenocarcinoma expected to undergo surgery (Whipple procedure)
  • Adequate white blood cell count (≥ 3,000/microL), platelet count (≥ 75,000/microL), and hemoglobin (≥ 8 g/dL)
  • Adequate liver function with total bilirubin ≤ 1.5 times upper limit of normal, AST ≤ 2.5 times upper limit of normal, and ALT ≤ 2.5 times upper limit of normal
  • Adequate kidney function with creatinine clearance > 30 mL/min
  • Age 18 years or older
  • Male or female
  • Willingness and ability to sign informed consent
  • Ability to provide blood and stool samples
  • Consent to baseline tumor biopsy and colonoscopy for FMT delivery
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Not Eligible

You will not qualify if you...

  • Younger than 18 years old
  • Positive gastrointestinal infection
  • Pancreatic cancer staged as T1N0
  • Higher risk for colonization with multidrug-resistant organisms (MDROs)
  • Received antibiotics within the last 48 hours (eligible if antibiotics stopped at least 48 hours before study start)
  • Active viral, bacterial, or fungal infection
  • History of inflammatory bowel disease, radiation enteritis, or colitis
  • Pregnant or breastfeeding women
  • Women of child-bearing potential with positive or refused pregnancy test
  • Diagnosis of immunodeficiency
  • White blood cell count > 12 x 10^9/L or temperature > 38°C
  • Neutropenia (absolute neutrophil count < 1500)
  • Swallowing dysfunction or chronic aspiration
  • Delayed gastric emptying
  • History of intestinal obstruction
  • Acute worsening of other medical conditions
  • Severely immunocompromised
  • Allergies to any drugs used in the trial (antibiotics, loperamide, laxatives)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

F

Florencia McAllister, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Fecal Microbial Transplants for the Treatment of Pancreatic Cancer | DecenTrialz