Clinical trial · Interventional
Fecal Microbial Transplants for the Treatment of Pancreatic Cancer
Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer
NCT04975217CI-TRIAL-00112470suspendedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI request
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fecal Microbiota Transplantation | Procedure | — | UNRESOLVED |
| Fecal Microbiota Transplantation Capsule | Drug | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Resection | Procedure | — | UNRESOLVED |
| Therapeutic Colonoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (FMT, FMT capsules)
- description
- 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).
- interventionNames
- Procedure: Fecal Microbiota Transplantation
- Drug: Fecal Microbiota Transplantation Capsule
- Other: Questionnaire Administration
- Procedure: Resection
- Procedure: Therapeutic Colonoscopy
Primary outcomes (1)
- measure
- Incidence of adverse events
- timeFrame
- Up to 30 days after surgery
- description
- Will be measured by Common Terminology Criteria for Adverse Events, version 5.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.