NCT04975217

Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Fecal Microbiota Transplantation	Undergo FMT
DRUG	Fecal Microbiota Transplantation Capsule	Given PO
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Resection	Undergo standard of care resection
PROCEDURE	Therapeutic Colonoscopy	Undergo colonoscopy

Timeline

• Start date: 2021-12-14
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-07-23
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study