Fecal Microbial Transplants for the Treatment of Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Early Phase 1
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 10 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
PI request
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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)
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
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).
Procedure: Fecal Microbiota Transplantation · Drug: Fecal Microbiota Transplantation Capsule · Other: Questionnaire Administration · Procedure: Resection · Procedure: Therapeutic Colonoscopy
Fecal Microbiota Transplantation PROCEDURE
Undergo FMT
Fecal Microbiota Transplantation Capsule DRUG
Given PO
Questionnaire Administration OTHER
Ancillary studies
Resection PROCEDURE
Undergo standard of care resection
Therapeutic Colonoscopy PROCEDURE
Undergo colonoscopy
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Incidence of adverse events
Time frame: Up to 30 days after surgery
Will be measured by Common Terminology Criteria for Adverse Events, version 5.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
M D Anderson Cancer CenterHouston, Texas, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- M.D. Anderson Cancer Center
- Study start
- Dec 14, 2021 Actual
- Primary completion
- Dec 31, 2026 Estimated
- Study completion
- Dec 31, 2026 Estimated
- First posted
- Jul 23, 2021 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026