Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

NCT ID: NCT04975217

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-14
• Study Completion Date: 2026-12-31

Brief Summary

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.

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type: PROCEDURE

Undergo FMT

Fecal Microbiota Transplantation Capsule

Intervention Type: DRUG

Given PO

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Resection

Intervention Type: PROCEDURE

Undergo standard of care resection

Therapeutic Colonoscopy

Intervention Type: PROCEDURE

Undergo colonoscopy

Interventions

Fecal Microbiota Transplantation

Undergo FMT

Intervention Type: PROCEDURE

Fecal Microbiota Transplantation Capsule

Given PO

Intervention Type: DRUG

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Resection

Undergo standard of care resection

Intervention Type: PROCEDURE

Therapeutic Colonoscopy

Undergo colonoscopy

Intervention Type: PROCEDURE

Other Intervention Names

Fecal Material Transplantation; Fecal Transplantation; FMT; Poo Transplant; Poop Transplant; Stool Transplant; Fecal Microbiota Preparation Delivery Capsule; FMPCapDE; FMT Capsule DE; FMT Capsule Delivery; FMT DE Capsule; Surgical Resection

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florencia McAllister, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Florencia McAllister, MD

Role: CONTACT

fmcallister@mdanderson.org

713-563-4743

Facility Contacts

Florencia McAllister

Role: primary

fmcallister@mdanderson.org

713-563-4743

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2021-03484

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-0788

Identifier Type: OTHER

Identifier Source: secondary_id

2020-0788

Identifier Type: -

Identifier Source: org_study_id