Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

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: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Fecal Microbiota Transplantation; Drug: Fecal Microbiota Transplantation Capsule; Procedure: Resection; Procedure: Therapeutic Colonoscopy

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Will be measured by Common Terminology Criteria for Adverse Events, version 5.	Up to 30 days after surgery

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

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: Therapeutics; Biological Therapy; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Parturition; Fecal Microbiota Transplantation
• 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