Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title: Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Pancreatic Ductal Adenocarcinoma

• NCT number: NCT04975217
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: Florencia McAllister, MD
• Phone: 713-563-4743
• Email: fmcallister@mdanderson.org
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 14, 2021
• Completion date: December 31, 2026