Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

May 19, 2026 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the safety, tolerability, and feasibility of fecal microbiota transplantation (FMT) in resectable patients with pancreatic ductal adenocarcinoma (PDAC).

SECONDARY OBJECTIVES:

I. To assess changes in gut microbiome of PDAC patients after FMT. II. To assess changes in oral microbiome of PDAC patients after FMT. III. To assess changes in tumor microbiome of PDAC patients after FMT. IV. To determine immunological/molecular changes in the tumor after FMT.

OUTLINE:

Patients undergo FMT during colonoscopy. Patients also receive FMT capsules orally (PO) once weekly (QW) for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care resection of tumor(s).

After completion of study treatment, patients are followed up at 2 weeks and 30, 60, 90, and 180 days after surgery.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (FMT, FMT capsules)
Patients undergo FMT during colonoscopy. Patients also receive FMT capsules PO QW for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care resection of tumor(s).
Other: Questionnaire Administration
Ancillary studies
Procedure: Fecal Microbiota Transplantation
Undergo FMT
Other Names:
  • Fecal Material Transplantation
  • Fecal Transplantation
  • FMT
  • Poo Transplant
  • Poop Transplant
  • Stool Transplant
Drug: Fecal Microbiota Transplantation Capsule
Given PO
Other Names:
  • Fecal Microbiota Preparation Delivery Capsule
  • FMPCapDE
  • FMT Capsule DE
  • FMT Capsule Delivery
  • FMT DE Capsule
Procedure: Resection
Undergo standard of care resection
Other Names:
  • Surgical Resection
Procedure: Therapeutic Colonoscopy
Undergo colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 30 days after surgery
Will be measured by Common Terminology Criteria for Adverse Events, version 5.
Up to 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Florencia McAllister, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0788 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-03484 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe