Fecal Microbiota Transplantation for Pancreatic Cancer

Overseen By Florencia McAllister, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antibiotics, Loperamide, Laxatives

Disqualifiers: Positive GI infection, Immunodeficiency, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether fecal microbiota transplantation (FMT), which transplants beneficial microbes from stool, can help treat pancreatic cancer. Researchers aim to determine if FMT can safely control the disease when combined with regular tumor-removal surgery. Participants receive FMT during a colonoscopy and then orally through capsules for four weeks. This trial suits those diagnosed with pancreatic ductal adenocarcinoma who plan to undergo surgery and can provide blood and stool samples. As an Early Phase 1 trial, this research focuses on understanding how FMT works in people, offering participants a chance to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial information 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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fecal microbiota transplantation (FMT), in both traditional form and as capsules, is generally safe for treating various conditions, including those related to the pancreas. Most side effects are mild to moderate, indicating they are not serious.

Using FMT in cancer treatment is a newer approach but appears promising. Studies have found that FMT is safe and practical. While side effects can vary, they are usually mild and temporary, such as an upset stomach.

FMT capsules represent a newer method of delivering the treatment and aim to offer similar benefits. Early research suggests they are also safe. Both forms of FMT are being tested for their potential to help manage pancreatic cancer, showing promise with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for pancreatic cancer, which typically involve chemotherapy, radiation, and surgery, the new approach using fecal microbiota transplantation (FMT) is unique because it focuses on altering the gut microbiome to impact cancer progression. Researchers are excited about this treatment because FMT introduces healthy bacteria to potentially boost the body's immune response against cancer cells. Additionally, the treatment is delivered in a novel way: both through a colonoscopy and oral capsules, offering a potentially less invasive and more targeted method to support traditional cancer therapies. This innovative strategy has the potential to complement existing treatments by addressing the disease from a completely different angle.

What evidence suggests that fecal microbial transplantation might be an effective treatment for pancreatic cancer?

Research has shown that fecal microbiota transplantation (FMT) holds promise for treating pancreatic cancer. In this trial, participants will undergo FMT during colonoscopy and receive FMT capsules weekly for four weeks. FMT introduces healthy bacteria to the gut, which might help control tumor growth. Studies have found that FMT can shrink tumors and increase gut bacterial diversity, benefiting health. Researchers are also studying FMT for its potential to enhance cancer treatment effectiveness and reduce side effects. Although still in early stages, these findings suggest FMT could be a valuable tool against pancreatic cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Florencia McAllister, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patients that are seen at MD Anderson Cancer Center

I am willing and able to sign a consent form.

Consent and ability to give blood and stool samples

Exclusion Criteria

I am not allergic to antibiotics, loperamide, or laxatives.

Pregnant and breastfeeding women

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo FMT during colonoscopy and receive FMT capsules orally once weekly for 4 weeks

4 weeks

1 visit (in-person for colonoscopy), 4 visits (virtual or in-person for capsule administration)

Surgery

Patients undergo standard of care resection of tumor(s)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

5 visits (in-person) at 2 weeks, 30, 60, 90, and 180 days after surgery

What Are the Treatments Tested in This Trial?

Interventions

• Fecal Microbial Transplantation
• Fecal Microbial Transplantation Capsule

Trial Overview

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.

How Is the Trial Designed?

Group I: Treatment (FMT, FMT capsules) Experimental Treatment 5 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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a study involving 7 patients with mild to moderate ulcerative colitis, fecal microbiota transplantation (FMT) achieved a donor similarity index (DSI) of 40-50% in about two-thirds of recipients, indicating some level of microbiota engraftment.

Despite achieving this level of engraftment, only one patient experienced a temporary clinical improvement, suggesting that while FMT can alter the microbiota, its efficacy in achieving lasting remission in ulcerative colitis may require further investigation and optimization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Level Engraftment and Improvement following a Single Colonoscopic Administration of Fecal Microbiota to Patients with Ulcerative Colitis. Damman, CJ., Brittnacher, MJ., Westerhoff, M., et al.[2022]

In a study of 15 patients with steroid-dependent ulcerative colitis (UC), a step-up fecal microbiota transplantation (FMT) strategy led to clinical improvement in 57.1% of patients, allowing them to discontinue steroid use.

The successful treatment was associated with significant changes in gut microbiota composition, resembling that of the donor, and no severe adverse events were reported, indicating the safety of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. Cui, B., Li, P., Xu, L., et al.[2022]

Fecal microbiota transplantation (FMT) is highly effective for treating Clostridium difficile infection (CDI), with a 90% resolution of diarrhea reported in 867 patients across 33 studies, and a 94% resolution after repeated FMT in a randomized controlled trial with 16 participants.

FMT shows promise in treating ulcerative colitis, with remission rates varying from 0% to 68% in 106 patients, while its efficacy in Crohn's disease, chronic constipation, pouchitis, and irritable bowel syndrome remains inconclusive due to limited data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. Rossen, NG., MacDonald, JK., de Vries, EM., et al.[2022]

Faecal microbiota transplantation (FMT) has shown significant benefits in treating ulcerative colitis, with four randomized controlled trials indicating its effectiveness compared to placebo.

Research is ongoing to optimize donor and patient selection for FMT, and complementary strategies like pre-antibiotics are being explored to enhance treatment efficacy, although data for Crohn's disease and pouchitis are still limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of faecal microbiota transplantation in the treatment of inflammatory bowel disease. Haifer, C., Leong, RW., Paramsothy, S.[2021]

In a clinical trial involving 22 patients with active ulcerative colitis (UC), capsulized fecal microbiota transplantation (FMT) significantly altered gut fungal diversity and composition, which was linked to treatment outcomes.

Patients who achieved remission after capsulized FMT showed a decrease in harmful fungi and an increase in beneficial fungi, indicating that specific fungal communities may play a role in the effectiveness of FMT for UC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specific fungi associated with response to capsulized fecal microbiota transplantation in patients with active ulcerative colitis. Chen, Q., Fan, Y., Zhang, B., et al.[2023]

Fecal microbiota transplantation (FMT) showed effectiveness in treating active ulcerative colitis (UC) in a small study of 7 patients, with all participants experiencing improvements in their Mayo scores after the procedure.

While some patients experienced mild and transient side effects like fever and diarrhea, no severe adverse reactions were reported, suggesting that FMT is a relatively safe option for managing active UC, although further research is needed to assess long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A pilot study of treating ulcerative colitis with fecal microbiota transplantation]. Ren, R., Sun, G., Yang, Y., et al.[2022]

Fecal microbiota transplantation (FMT) was found to be a well-tolerated and effective treatment for patients with mild-to-moderate ulcerative colitis (UC), showing a higher rate of clinical remission compared to standard care after 8 weeks (84.6% vs. 70.4%).

Patients receiving FMT also experienced a more significant improvement in gut microbiota composition and a greater reduction in the Mayo score, indicating better overall clinical outcomes compared to those on standard mesalazine therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Tkach, S., Dorofeyev, A., Kuzenko, I., et al.[2023]

Faecal microbiota transplantation (FMT) showed variable efficacy in treating ulcerative colitis (UC), with one donor achieving 100% efficacy while another only 36%, highlighting the importance of donor selection.

The effective donor's gut microbiome exhibited long-term stability and higher species evenness, which were associated with better clinical outcomes, suggesting that these characteristics could be key metrics for selecting FMT donors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbial determinants of effective donors in faecal microbiota transplantation for UC. Haifer, C., Luu, LDW., Paramsothy, S., et al.[2023]

In 2019, 31 FMT centers across 17 European countries performed a total of 1,874 fecal microbiota transplants, primarily for Clostridioides difficile infection (CDI), indicating that FMT is a common treatment for this condition.

Despite the high safety standards and adherence to guidelines observed in these centers, only about 10% of the estimated patients needing FMT for recurrent CDI in Europe received the treatment, highlighting a significant gap in coverage and the need for increased clinical awareness and activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of Faecal Microbiota Transplantation (FMT) in Europe: A Europe-wide survey. Baunwall, SMD., Terveer, EM., Dahlerup, JF., et al.[2022]

In a study of 176 ulcerative colitis patients who underwent fecal microbiota transplantation (FMT), good adherence to repeated FMT was linked to longer-lasting clinical responses, highlighting the importance of following treatment recommendations for better outcomes.

The study found that patient satisfaction with FMT was significantly influenced by the clinical response at one month post-treatment, and adverse events were associated with the laboratory preparation process, indicating that both efficacy and safety are crucial for patient acceptance of FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing patient adherence to fecal microbiota transplantation maintains the long-term clinical effects in ulcerative colitis. Li, Q., Zhang, T., Ding, X., et al.[2021]

The study demonstrated that daily oral administration of frozen encapsulated fecal microbiota transplantation (cFMT) is safe and well-tolerated in patients with mild to moderate ulcerative colitis (UC), with no treatment-related adverse events reported.

Two out of six subjects receiving cFMT achieved clinical remission, suggesting that cFMT may help maintain beneficial changes in gut microbiota and improve clinical outcomes, although further research is needed to confirm these findings and address home storage issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study. Crothers, JW., Chu, ND., Nguyen, LTT., et al.[2022]

Faecal microbiota transplantation (FMT) has shown effectiveness in inducing remission in active ulcerative colitis (UC), with a clinical remission rate of 28% in FMT patients compared to 9% in placebo groups based on a meta-analysis of randomized controlled trials involving 277 patients.

The study found no major short-term safety concerns associated with FMT, suggesting it is a safe option for patients with UC, although further research is needed to optimize treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review with meta-analysis: faecal microbiota transplantation for the induction of remission for active ulcerative colitis. Costello, SP., Soo, W., Bryant, RV., et al.[2022]

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This early phase I trial examines the safety and feasibility of fecal microbial transplants (FMT) in pancreatic cancer patients.

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This early phase I trial examines the safety and effects of fecal microbial transplants in treating patients with pancreatic cancer.

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Fecal Microbial Transplants for the Treatment of Pancreat...

To assess the safety, tolerability, and feasibility of fecal microbiota transplantation (FMT) in resectable patients with pancreatic ductal ...