Pancreatic Ductal AdenocarcinomaEarly Phase 1NCT04975217
Fecal Microbial Transplants for the Treatment of Pancreatic Cancer
A Early Phase 1 study testing Fecal Microbiota Transplantation, Fecal Microbiota Transplantation Capsule and Questionnaire Administration in people with Pancreatic Ductal Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Fecal Microbiota Transplantation, Fecal Microbiota Transplantation Capsule and Questionnaire Administration
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2021to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that are seen at MD Anderson Cancer Center
- Patients with pancreatic ductal adenocarcinoma (PDAC) diagnosis who are expected to have surgery (Whipple)
- Adequate hematological function, defined by white blood cell (WBC) count ≥ 3,000/microL, platelet count ≥75,000/microL, and Hgb ≥ 8 g/dL
- Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN), an AST, level ≤ 2.5 × ULN, and an ALT level ≤ 2.5 × ULN
- Adequate renal function defined by an estimated creatinine clearance >30 mL/min according to the Cockcroft-Gault formula or by a creatinine clearance measurement from a 24-hour urine collection
- Age 18 years and above
Show all 11Show fewer
- Male or female
- Willingness and ability to sign an informed consent
- Consent and ability to give blood and stool samples
- Consent to undergo a baseline core biopsy and colonoscopy for FMT delivery
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Who cannot join
- Age younger than 18 years
- Positive GI infection
- Patients with pancreatic cancer Stage T1N0
- Individuals at higher risk of colonization with MDROs
- Patient received antibiotics in the last 48 hours. Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to start of study
- Patients with active viral, bacterial or fungal infection
Show all 18Show fewer
- History of inflammatory bowel disease, and/or radiation enteritis or colitis
- Pregnant and breastfeeding women
- Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test
- Has a diagnosis of immunodeficiency
- Peripheral WBC >12 x 10^9/L and/or temperature >38 degrees Celsius
- Subjects with neutropenia (ANC <1500)
- Swallowing dysfunction or known chronic aspiration
- Delayed gastric emptying
- History of intestinal obstruction
- Acute exacerbation of underlying comorbid condition
- Severely immunocompromised patients
- Allergies to drugs included as part of trial (antibiotics, loperamide or laxatives)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the safety, tolerability, and feasibility of fecal microbiota transplantation (FMT) in resectable patients with pancreatic ductal adenocarcinoma (PDAC).
SECONDARY OBJECTIVES:
- 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
- Being tested
- Fecal Microbiota Transplantation, Fecal Microbiota Transplantation Capsule, Questionnaire Administration, Resection, Therapeutic Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationProcedure or surgery
Also called Fecal Material Transplantation, Fecal Transplantation, FMT, Poo Transplant
Undergo FMT
Fecal Microbiota Transplantation CapsuleDrug
Also called Fecal Microbiota Preparation Delivery Capsule, FMPCapDE, FMT Capsule DE, FMT Capsule Delivery
Given PO
Questionnaire AdministrationOther
Ancillary studies
ResectionProcedure or surgery
Also called Surgical Resection
Undergo standard of care resection
Therapeutic ColonoscopyProcedure or surgery
Undergo colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (FMT, FMT capsules) | Experimental | Patients undergo FMT during colonoscopy. Patients also receive FMT capsules PO QW for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care resection of tumor(s). Receives: Procedure: Fecal Microbiota Transplantation; Drug: Fecal Microbiota Transplantation Capsule; Other: Questionnaire Administration; Procedure: Resection; Procedure: Therapeutic Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Will be measured by Common Terminology Criteria for Adverse Events, version 5.
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start14 Dec 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: PI request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florencia McAllister, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975217
- Sponsor's protocol ID
- 2020-0788
- Other IDs
- NCI-2021-03484, 2020-0788
- Status last verified
- Mar 2026
- First submitted
- 25 May 2021
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04975217
- Acronym / sponsor ID
- 2020-0788
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: PI request
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the safety, tolerability, and feasibility of fecal microbiota transplantation (FMT) in resectable patients with pancreatic ductal adenocarcinoma (PDAC).
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (FMT, FMT capsules) | Experimental | Procedure: Fecal Microbiota Transplantation, Drug: Fecal Microbiota Transplantation Capsule, Other: Questionnaire Administration, Procedure: Resection, Procedure: Therapeutic ColonoscopyPatients undergo FMT during colonoscopy. Patients also receive FMT capsules PO QW for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care resection of tumor(s). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients that are seen at MD Anderson Cancer Center
- Patients with pancreatic ductal adenocarcinoma (PDAC) diagnosis who are expected to have surgery (Whipple)
- Adequate hematological function, defined by white blood cell (WBC) count ≥ 3,000/microL, platelet count ≥75,000/microL, and Hgb ≥ 8 g/dL
- Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN), an AST, level ≤ 2.5 × ULN, and an ALT level ≤ 2.5 × ULN
- Adequate renal function defined by an estimated creatinine clearance >30 mL/min according to the Cockcroft-Gault formula or by a creatinine clearance measurement from a 24-hour urine collection
Key exclusion criteria (18 listed)
- Age younger than 18 years
- Positive GI infection
- Patients with pancreatic cancer Stage T1N0
- Individuals at higher risk of colonization with MDROs
- Patient received antibiotics in the last 48 hours. Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to start of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota TransplantationAlso: Fecal Material Transplantation, Fecal Transplantation, FMT, Poo TransplantUndergo FMT | Procedure or surgery | Treatment (FMT, FMT capsules) |
| Fecal Microbiota Transplantation CapsuleAlso: Fecal Microbiota Preparation Delivery Capsule, FMPCapDE, FMT Capsule DE, FMT Capsule DeliveryGiven PO | Drug | Treatment (FMT, FMT capsules) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (FMT, FMT capsules) |
| ResectionAlso: Surgical ResectionUndergo standard of care resection | Procedure or surgery | Treatment (FMT, FMT capsules) |
| Therapeutic ColonoscopyUndergo colonoscopy | Procedure or surgery | Treatment (FMT, FMT capsules) |
Primary outcome
Incidence of adverse events
Time frame: Up to 30 days after surgery
Will be measured by Common Terminology Criteria for Adverse Events, version 5.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
Related trials for Pancreatic Ductal Adenocarcinoma
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florencia McAllister, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fecal Microbiota Transplantation, Fecal Microbiota Transplantation Capsule and Questionnaire Administration in people with Pancreatic Ductal Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.