Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Pancreatic Cancer

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).

Fecal Microbiota Transplantation

Fecal Microbiota Transplantation Capsule

Questionnaire Administration

Resection

Therapeutic Colonoscopy

Florencia McAllister, MD

Florencia McAllister

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.

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.

Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer

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

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fecal Microbial Transplants for the Treatment of Pancreatic Cancer	NCT04975217	Pancreatic Duct...	Fecal Microbiot... Fecal Microbiot... Questionnaire A... Resection Therapeutic Col...	18 Years -	M.D. Anderson Cancer Center
Fecal Microbial Transplants for the Treatment of Pancreatic Cancer	NCT04975217	Pancreatic Duct...	Fecal Microbiot... Fecal Microbiot... Questionnaire A... Resection Therapeutic Col...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for therapeutic colonoscopy