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

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.

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.

What data supports the effectiveness of the treatment Fecal Microbiota Transplantation (FMT) for pancreatic cancer?

FMT has shown effectiveness in treating conditions like ulcerative colitis, where it helps restore healthy gut bacteria balance. This suggests potential benefits for other diseases involving gut microbiota disturbances, although specific data for pancreatic cancer is not available. ^{1 2 3 4 5}

Is fecal microbiota transplantation (FMT) safe for humans?

Research on fecal microbiota transplantation (FMT) for conditions like ulcerative colitis suggests that it is generally safe for humans, with studies focusing on its safety and feasibility. ^{4 6 7 8 9}

How is fecal microbiota transplantation (FMT) unique for treating pancreatic cancer?

FMT is unique because it involves transferring healthy bacteria from a donor's stool to a patient's gut, which is different from traditional cancer treatments like chemotherapy or radiation that target cancer cells directly. This approach aims to restore a healthy balance of gut bacteria, which may influence the body's immune response and overall health. ^{1 4 10 11 12}

Research Team

Florencia McAllister, MD

Principal Investigator

M.D. Anderson Cancer Center

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.

Inclusion Criteria

I am 18 years old or older.

Patients that are seen at MD Anderson Cancer Center

I am willing and able to sign a consent form.

Exclusion Criteria

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

Pregnant and breastfeeding women

I am under 18 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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 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]

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]

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]

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]

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 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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The use of Faecal Microbiota Transplantation (FMT) in Europe: A Europe-wide survey. [2022]

2. Switzerland 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The role of faecal microbiota transplantation in the treatment of inflammatory bowel disease. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Enhancing patient adherence to fecal microbiota transplantation maintains the long-term clinical effects in ulcerative colitis. [2021]

6. China pubmed.ncbi.nlm.nih.gov

[A pilot study of treating ulcerative colitis with fecal microbiota transplantation]. [2022]

7. England 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Systematic review with meta-analysis: faecal microbiota transplantation for the induction of remission for active ulcerative colitis. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Low Level Engraftment and Improvement following a Single Colonoscopic Administration of Fecal Microbiota to Patients with Ulcerative Colitis. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Specific fungi associated with response to capsulized fecal microbiota transplantation in patients with active ulcerative colitis. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Microbial determinants of effective donors in faecal microbiota transplantation for UC. [2023]