RecruitingPhase 1NCT06393400

CHemotherapy and Stool Transplant in PDAC (CHASe-PDAC)

An Open-label, Single-arm, Phase 1 Study of the Combination of FMT and Gemcitabine with Nab-paclitaxel As First-line Therapy in Patients with Advanced Pancreatic Ductal Adenocarcinoma.

Sponsor

John Lenehan

Enrollment

20 participants

Start Date

Jan 8, 2025

Study Type

INTERVENTIONAL

Conditions

Unresectable or Metastatic Advanced Pancreatic Ductal Adenocarcinoma

Summary

To confirm the safety of combining oral fecal microbiota transplantation (FMT) with gemcitabine and nab-paclitaxel chemotherapy as first line treatment in patients with unresectable or metastatic pancreatic ductal adenocarcinoma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Fecal Microbiota Transplantation, a drug called Gemcitabine, and others for people with unresectable or metastatic advanced pancreatic ductal adenocarcinoma. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFecal Microbiota Transplantation

Fecal Microbiota Transplantation with 100 g of healthy donor stool in 36-40 oral capsules once Other Names: * FMT * Stool Transplant * Poop Transplant

DRUGPEG3350

Polyethylene Glycol 3350 17 g oral dissolved in 4 litres of water consumed the evening before FMT. Other Names: * PEG3350 * RestoraLAX * MiraLAX

DRUGGemcitabine

Gemcitabine 1000 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle. Other Names: \- Gemzar

DRUGnab-Paclitaxel

nab-Paclitaxel 125 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle. Other Names: \- Abraxane

Locations(1)

Verspeeten Family Cancer Centre (formerly known as the London Regional Cancer Program) London Health Sciences Centre

London, Ontario, Canada

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NCT06393400