Fecal Microbiota Transplantation for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Florencia McAllister, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antibiotics, Loperamide, Laxatives

Disqualifiers: Positive GI infection, Immunodeficiency, Pregnancy, others

No Placebo Group

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.

Trial 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 (Virus Therapy)
• Fecal Microbial Transplantation Capsule (Virus Therapy)

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 Canada for the following indications:

Approved in Canada as Fecal Microbiota Transplantation for:

• Recurrent Clostridioides difficile infection

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3107

Patients Recruited

1,813,000+

Findings from Research

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 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]

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]

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]