RECRUITING

Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Study Using Fecal Microbial Transplants in Patients with Pancreatic Cancer

Quick Facts

Study Start:2021-12-14

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04975217

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Florencia McAllister, MD

CONTACT

713-563-4743

fmcallister@mdanderson.org

Principal Investigator

Florencia McAllister, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Florencia McAllister, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Registration Dates

Study Start Date2021-12-14

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-12-14

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Pancreatic Ductal Adenocarcinoma