Testing Fecal Microbiota Transplantation with PEG3350 for unresectable or metastatic advanced pancreatic ductal
Official title: 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.
Interventions
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
PEG3350
Polyethylene Glycol 3350 17 g oral dissolved in 4 litres of water consumed the evening before FMT. Other Names: * PEG3350 * RestoraLAX * MiraLAX
Gemcitabine
Gemcitabine 1000 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle. Other Names: \- Gemzar
nab-Paclitaxel
nab-Paclitaxel 125 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle. Other Names: \- Abraxane
Canadian Sites (1)
Verspeeten Family Cancer Centre (formerly known as the London Regional Cancer Program) London Health Sciences Centre
London, Ontario, Canada
Eligibility Criteria
See who this study is looking for27 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients with ECOG performance of 0-2
- +Patients must have a confirmed diagnosis of unresectable or metastatic pancreatic ductal adenocarcinoma. Diagnosis confirmation may include pathologic assessment or radiographic/biomarkerBiomarkerSomething measurable in the body used as a signal of what is happening.Read more → determination of PDAC when obtaining a tumour sample is not feasible/successful. The latter case requires review at the Pancreas Multi-disciplinary Case Conference (MCC)
- +Patients must be 18-years old or older
- +Patients must be able to provide written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and understand the infectious risks associated with FMT administration
- +Patients must understand that there are non-infectious risks associated with FMT administration
- +Ability to ingest capsules
- +Understand that data regarding the long-term safety risk of FMT are lacking
- +Have evaluable disease as per RECIST version 1.1
- +Patients who have consented to treatment with first-line gemcitabine with nab-paclitaxel at the discretion of their primary oncologist. Patients must receive at least one dose of both chemotherapy agents to be considered eligible for evaluation.
- +Patients may receive other localized therapies with palliative intent while on therapy to include external beam radiation to areas of metastatic disease. StratificationStratificationSplitting participants into subgroups first, so groups stay balanced.Read more → of outcomes will include identifying patients that receive palliative radiation to the primary tumour itself.
Exclusion
- −Severe dietary allergies (e.g. shellfish, nuts, seafood)
- −Has a diagnosis of immunodeficiency (e.g. HIV, organ transplantation)
- −This includes HIV or AIDS-related illness, or active HBV and HCV
- −Ongoing use of antibiotics or previous use of antibiotics within 7 days prior to the FMT procedure
- −Presence of a chronic intestinal disease (e.g. Celiac, malabsorption, primary colonic tumor)
- −Presence of absolute contra-indications to FMT administration
- −Toxic megacolon
- −Inflammatory bowel disease
- −Has serious concomitant illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, uncontrolled hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, and inflammatory bowel disorders
- −Has an active infection requiring systemic therapy
- −Patient has received a live vaccine within 4 weeks prior to the first dose of treatment
- −Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- −Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- −Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screeningScreeningThe checks done before joining, to see whether a study fits.Read more → or screening visit
- −Previously received cytotoxic chemotherapy with curative or non-curative intent for PDAC
- −Probiotic supplements and food products labeled as containing probiotics must be discontinued a minimum of 72 hours before FMT administration and are not permitted during the first 3 months of chemotherapy treatment
- −Special considerations include patients who are unable to tolerate the combination of gemcitabine with nab-paclitaxel, and subsequently after starting chemotherapy are transitioned to gemcitabine alone at the discretion of their treating oncologist. Such patients will not be removed or disqualified from continuing in the study but their clinical outcomes will be stratifiedStratificationSplitting participants into subgroups first, so groups stay balanced.Read more → between those who received nab-paclitaxel with gemcitabine and those who transitioned to gemcitabine alone. In general, this scenario is not expected to commonly occur in this trial.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
What is being given or done in this study: Fecal Microbiota Transplantation, PEG3350, Gemcitabine, nab-Paclitaxel.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 20 people.
The study is currently expected to finish around February 2028.
The main measurement is taken over: Approximately end of year 4 (Study Completion).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → — measured over Approximately end of year 4 (Study Completion).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06393400 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Fecal Microbiota TransplantationDrug
Fecal Microbiota Transplantation with 100 g of healthy donor stool in 36-40 oral capsules once Other Names: * FMT * Stool Transplant * Poop Transplant
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PEG3350Drug
Polyethylene Glycol 3350 17 g oral dissolved in 4 litres of water consumed the evening before FMT. Other Names: * PEG3350 * RestoraLAX * MiraLAX
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About GemcitabineDrug
Gemcitabine 1000 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle. Other Names: \- Gemzar
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About nab-PaclitaxelDrug
nab-Paclitaxel 125 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle. Other Names: \- Abraxane
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Approximately end of year 4 (Study Completion).
The study as a whole is currently expected to finish around 2028-02.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 20 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: London, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.