What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer include chemotherapy, radiation therapy, and surgery. Chemotherapy can cause side effects such as nausea, vomiting, fatigue, hair loss, and increased risk of infection. Radiation therapy may lead to skin irritation, fatigue, and gastrointestinal issues. Surgery carries risks of infection, bleeding, and complications related to anesthesia. For treatments similar to Fecal Microbial Transplant (FMT), such as probiotics and prebiotics, side effects are generally mild but can include gastrointestinal discomfort, bloating, and, in rare cases, infections, especially in immunocompromised patients.

What prior FDA approvals exist?

FDA-approved treatments for pancreatic cancer primarily include systemic chemotherapy regimens such as gemcitabine, FOLFIRINOX (a combination of fluorouracil, leucovorin, irinotecan, and oxaliplatin), and gemcitabine combined with nanoparticle albumin-bound paclitaxel (nab-paclitaxel). These treatments aim to improve symptoms and prolong survival in patients with advanced pancreatic cancer. Currently, there are no FDA-approved treatments involving fecal microbial transplants or the introduction of beneficial gut bacteria for pancreatic cancer.

What other types of research exist?

Promising novel alternatives to Fecal Microbial Transplant for pancreatic cancer patients include: 1) Probiotic therapy, which involves the administration of specific beneficial bacteria strains to modulate the gut microbiome. 2) Postbiotic therapy, which uses metabolic byproducts of beneficial bacteria to exert therapeutic effects. 3) Microbiome-derived metabolites, which are compounds produced by gut bacteria that can influence cancer progression and treatment response. These alternatives aim to harness the benefits of gut microbiota modulation without the need for direct fecal material transplantation.

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Virus Therapy

Fecal Microbiota Transplantation for Pancreatic Cancer

Phase < 1

Recruiting

Led By Florencia McAllister

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after surgery

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from colonoscopy procedure; reactions to FMT such as bloating, cramps or changes in bowel habits; risk of infection transfer through stool material; and possible allergic reactions to any medications used during the process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Side effects data

From 2020 Phase 1 & 2 trial • 50 Patients • NCT03106844

44%

Diarrhea

26%

Abdominal Pain

16%

Rectal Bleeding

12%

Constiption

10%

Fever

10%

Nausea

Fatigue

Vomiting

Heart Burn

Chills

Yeast Infection

Migraine

Anemia

IBD Flare

100%

80%

60%

40%

20%

Study treatment Arm

Treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fecal Microbiota Transplantation

2020

Completed Phase 2

~440

Resection

2020

Completed Phase 2

~1440

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer include chemotherapy agents such as gemcitabine, which inhibits DNA synthesis, and fluorouracil (FU) and capecitabine, which disrupt RNA and DNA function, leading to cancer cell death. These treatments aim to slow tumor growth and improve survival rates. Fecal Microbial Transplant (FMT) is an emerging treatment that introduces beneficial gut bacteria to potentially enhance the immune response and improve gut health, which may help control the disease. This is particularly relevant for pancreatic cancer patients as it offers a novel approach that could complement traditional therapies and improve overall treatment outcomes.