Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

NCT04975217 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 2020-0788NCI-2021-03484
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Will be measured by Common Terminology Criteria for Adverse Events, version 5.

  Up to 30 days after surgery

Study Arms (1)

Treatment (FMT, FMT capsules)

EXPERIMENTAL

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).

Procedure: Fecal Microbiota Transplantation; Drug: Fecal Microbiota Transplantation Capsule; Other: Questionnaire Administration; Procedure: Resection; Procedure: Therapeutic Colonoscopy

Interventions

Fecal Microbiota Transplantation PROCEDURE

Undergo FMT

Also known as: Fecal Material Transplantation, Fecal Transplantation, FMT, Poo Transplant, Poop Transplant, Stool Transplant

Treatment (FMT, FMT capsules)

Fecal Microbiota Transplantation Capsule DRUG

Given PO

Also known as: Fecal Microbiota Preparation Delivery Capsule, FMPCapDE, FMT Capsule DE, FMT Capsule Delivery, FMT DE Capsule

Treatment (FMT, FMT capsules)

Questionnaire Administration OTHER

Ancillary studies

Treatment (FMT, FMT capsules)

Resection PROCEDURE

Undergo standard of care resection

Also known as: Surgical Resection

Treatment (FMT, FMT capsules)

Therapeutic Colonoscopy PROCEDURE

Undergo colonoscopy

Treatment (FMT, FMT capsules)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

Fecal Microbiota Transplantation; Parturition

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Florencia McAllister, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florencia McAllister, MD

CONTACT

713-563-4743; fmcallister@mdanderson.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: July 23, 2021
• Study Start: December 14, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

US (1)