Trial Summary
What is the purpose of this trial?This trial examines if transferring healthy bacteria from donor stool to the gut can help control pancreatic cancer in patients scheduled for tumor removal surgery. The treatment aims to improve health by adding good bacteria to the gut. This approach has shown promise in treating various gastrointestinal disorders and is being explored for its potential to enhance cancer treatment outcomes.
What data supports the idea that Fecal Microbiota Transplantation for Pancreatic Cancer is an effective treatment?The available research does not provide specific data supporting the effectiveness of Fecal Microbiota Transplantation (FMT) for treating pancreatic cancer. Instead, the studies focus on its use for conditions like ulcerative colitis, where FMT has shown promise in improving symptoms and maintaining long-term benefits. Without direct evidence for pancreatic cancer, it's unclear how effective FMT would be for this condition compared to other treatments.345710
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, you must stop antibiotics at least 48 hours before starting the study.
Is Fecal Microbial Transplantation a promising treatment for pancreatic cancer?Fecal Microbial Transplantation (FMT) is a promising treatment because it has shown potential in helping patients with other conditions like ulcerative colitis by changing the gut bacteria. This suggests it might also help in treating pancreatic cancer by improving gut health.23789
What safety data exists for fecal microbiota transplantation?The safety of fecal microbiota transplantation (FMT) has been evaluated in several studies, primarily focusing on its use for ulcerative colitis and pouchitis. These studies, including pilot and systematic reviews, have generally aimed to assess the safety and feasibility of FMT, often finding it to be a promising treatment with a focus on long-term maintenance and patient adherence. However, specific safety data for pancreatic cancer is not directly addressed in the provided research.134611
Eligibility Criteria
This trial is for adults with pancreatic ductal adenocarcinoma scheduled for surgery. Participants must have normal liver and kidney function, not be pregnant or breastfeeding, able to give consent, provide samples, and not have had antibiotics in the last 48 hours. Exclusions include GI infections, immunodeficiency, swallowing issues, severe immune compromise, certain blood conditions or allergies to trial drugs.Treatment Details
The study tests fecal microbial transplants (FMT) via colonoscopy or capsules on patients with pancreatic cancer before tumor removal surgery. It aims to see if introducing healthy gut microbes can help control the disease. Patients will also complete questionnaires and undergo standard surgical procedures.
1Treatment groups
Experimental Treatment
Group I: Treatment (FMT, FMT capsules)Experimental Treatment5 Interventions
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).
Fecal Microbial Transplantation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Fecal Microbiota Transplantation for:
- Recurrent Clostridioides difficile infection
🇪🇺 Approved in European Union as Fecal Microbiota Transplantation for:
- Recurrent Clostridioides difficile infection
- Inflammatory bowel disease
🇨🇦 Approved in Canada as Fecal Microbiota Transplantation for:
- Recurrent Clostridioides difficile infection
Find a clinic near you
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
Loading ...
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
References
[A pilot study of treating ulcerative colitis with fecal microbiota transplantation]. [2022]To explore the procedure, effectiveness and safety of fecal microbiota transplantation (FMT) in patients with ulcerative colitis (UC).
Low Level Engraftment and Improvement following a Single Colonoscopic Administration of Fecal Microbiota to Patients with Ulcerative Colitis. [2022]Fecal microbiota transplantation (FMT) is an investigational treatment for diseases thought to involve alterations in the intestinal microbiota including ulcerative colitis (UC). Case reports have described therapeutic benefit of FMT in patients with UC, possibly due to changes in the microbiota. We measured the degree to which the transplanted microbiota engraft following FMT in patients with UC using a donor similarity index (DSI).
Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. [2022]The strategy of using fecal microbiota transplantation (FMT) for refractory ulcerative colitis (UC) remains unclear if single FMT failed to induce remission. This study aimed to evaluate the efficacy and safety of a designed step-up FMT strategy for the steroid-dependent UC.
Enhancing patient adherence to fecal microbiota transplantation maintains the long-term clinical effects in ulcerative colitis. [2021]The way to improve the long-term efficacy of fecal microbiota transplantation (FMT) in ulcerative colitis (UC) remains unclear. This study mainly dedicated to the UC patients' satisfaction with FMT and the importance of patients' adherence to repeated FMT for long-term clinical outcomes.
The role of faecal microbiota transplantation in the treatment of inflammatory bowel disease. [2021]Faecal microbiota transplantation (FMT) has emerged as a potent form of therapeutic microbial manipulation. There is much interest in exploring its potential in conditions such as inflammatory bowel disease (IBD) where disturbances in the gastrointestinal microbiota play a crucial role in disease pathogenesis.
Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study. [2022]Fecal microbiota transplantation (FMT) is a promising new strategy in the treatment of Inflammatory Bowel Disease, but long-term delivery systems are lacking. This randomized study was designed as a safety and feasibility study of long-term FMT in subjects with mild to moderate UC using frozen, encapsulated oral FMT (cFMT).
The use of Faecal Microbiota Transplantation (FMT) in Europe: A Europe-wide survey. [2022]Faecal microbiota transplantation (FMT) is an emerging treatment modality, but its current clinical use and organisation are unknown. We aimed to describe the clinical use, conduct, and potential for FMT in Europe.
Microbial determinants of effective donors in faecal microbiota transplantation for UC. [2023]Faecal microbiota transplantation (FMT) has variable efficacy in treating UC. Recently, oral lyophilised FMT was found to induce remission in patients with UC, with one donor having 100% efficacy compared with a second donor (36% efficacy). We characterised differences in the gut microbiota of these two donors with the aim of improving FMT donor selection.
Specific fungi associated with response to capsulized fecal microbiota transplantation in patients with active ulcerative colitis. [2023]Fecal microbiota transplantation (FMT) is a novel microbial treatment for patients with ulcerative colitis (UC). In this study, we performed a clinical trial of capsulized FMT in UC patients to determine the association between the gut fungal community and capsulized FMT outcomes.
Efficacy and safety of fecal microbiota transplantation via colonoscopy as add-on therapy in patients with mild-to-moderate ulcerative colitis: A randomized clinical trial. [2023]Growing evidence supports the effectiveness of fecal microbiota transplantation (FMT) in treating ulcerative colitis (UC), although its effects seem to depend on the method of introduction, the number of procedures, the donor material, and the severity of UC.
A Systematic Review of Fecal Microbiota Transplant for the Management of Pouchitis. [2023]Manipulation of the pouch microbiota via fecal microbiota transplant (FMT) has been theorized to be a promising therapeutic approach for pouchitis. The goal of this systematic review was to summarize the available, high-quality data on the efficacy and safety of FMT for acute and chronic pouchitis.