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CHemotherapy and Stool Transplant in PDAC (CHASe-PDAC)

NCT06393400 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-01-23

No results posted yet for this study

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.

Conditions

  • Unresectable or Metastatic Advanced Pancreatic Ductal Adenocarcinoma

Interventions

DRUG

Fecal 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

DRUG

PEG3350

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

DRUG

Gemcitabine

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

DRUG

nab-Paclitaxel

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

Sponsors & Collaborators

  • John Lenehan

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-08
Primary Completion
2028-02-29
Completion
2028-02-29

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06393400 on ClinicalTrials.gov