Fecal Microbiota for Colon Resection

Overseen By Kathryn Vera, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Minnesota

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Inflammatory bowel disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants or receiving cancer treatments like chemotherapy, you would not be eligible to participate.

What data supports the effectiveness of the treatment Orally administered preparation of fecal microbiota (MTP-101P) for colon resection?

Research shows that fecal microbiota transplantation (FMT) can be effective in treating conditions like ulcerative colitis, with some donors achieving high success rates. This suggests that using fecal microbiota could potentially help in other conditions, such as after colon surgery, by improving gut health. ^{1 2 3 4 5}

Is fecal microbiota transplantation (FMT) generally safe for humans?

Research on fecal microbiota transplantation (FMT) for conditions like ulcerative colitis shows that it is generally safe, with studies reporting only mild side effects. ^{1 2 4 6 7}

How is the treatment MTP-101P different from other treatments for colon resection?

MTP-101P is unique because it involves an orally administered preparation of fecal microbiota, which is different from traditional treatments that may not focus on altering gut bacteria. This approach is based on the idea that restoring a healthy balance of gut bacteria can aid in recovery, a concept that has shown promise in other conditions like ulcerative colitis and recurrent Clostridium difficile infections. ^{4 7 8 9 10}

What is the purpose of this trial?

This Phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of orally administered preparation of fecal microbiota (MTP-101P) in patients undergoing colon resection. We plan to enroll male and female patients, ages 18-75, diagnosed with colon polyps or early (stage I or II) colorectal cancer or medically refractory diverticulitis. We will recruit 40 patients total to receive the investigational product. This trial will inform development of future trials in treatment of colon and rectal surgery. Active drug is composed of highly purified, freeze-dried, fecal microbiota from healthy donors. This study will also allow for limited evaluation of pharmacokinetics in terms of donor microbiota engraftment. The exploratory objective is to evaluate engraftment of donor microbiota with this preparation and compare the results with data generated with the data generally from microbiota transplantation (IND28152).

Research Team

Cyrus Jahansouz

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for adults aged 18-75 who are undergoing colon resection due to unresectable polyps, early-stage (I or II) colorectal cancer not needing further chemotherapy, or chronic diverticulitis. Participants must be able to consent, provide fecal samples, and comply with study procedures.

Inclusion Criteria

I am willing and able to give my consent for treatment.

I can provide stool samples.

I am having surgery for polyps, early-stage colon cancer, or diverticulitis without needing further chemotherapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an orally administered preparation of fecal microbiota (MTP-101P) to evaluate safety and feasibility

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of microbiome engraftment and gut health

6 months

Treatment Details

Interventions

• Orally administered preparation of fecal microbiota (MTP-101P)

Trial Overview The trial tests the safety and feasibility of MTP-101P, an oral preparation of freeze-dried microbiota from healthy donors in patients after colon surgery. It aims to enroll 40 patients and will also explore how well the donor microbiota engrafts.

Participant Groups

Group I: Experimental group Experimental Treatment 1 Intervention

Male and female patients, ages 18-75, diagnosed with colon polyps or early (stage I or II) colorectal cancer or medically refractory diverticulitis.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

Out of 42 potential stool donors screened for fecal microbiota transplantation (FMT), a significant 57% of standard donors failed prescreening due to various health-related criteria, highlighting the challenges in donor recruitment.

Despite the challenges, most standard donors were informed about FMT as a treatment for Clostridium difficile infection and did not find the requirement for regular blood and stool testing inconvenient, suggesting potential for long-term donor retention with improved screening guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Donor Screening Experience for Fecal Microbiota Transplantation in Patients With Recurrent C. difficile Infection. Tariq, R., Weatherly, R., Kammer, P., et al.[2022]

Fecal microbiota transplantation (FMT) is significantly more effective than placebo in treating ulcerative colitis (UC), with a pooled odds ratio of 3.392 based on a systematic review of 37 studies involving 959 patients.

Administering FMT via the lower gastrointestinal tract and using a stool dosage over 275 grams were associated with higher remission rates, indicating these factors enhance the efficacy and safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of fecal microbiota transplantation for treating patients with ulcerative colitis: A systematic review and meta-analysis. Zhao, HL., Chen, SZ., Xu, HM., et al.[2021]

Preoperative immunonutrition, which included oral supplementation with arginine and omega-3 fatty acids for 7 days, did not significantly alter the overall composition of fecal microbiota in patients undergoing colon cancer surgery, as assessed in a study of 32 fecal samples from 32 patients.

While there were trends towards higher levels of beneficial bacteria in the immunonutrition group, these differences were not statistically significant, indicating that further research is needed to explore the relationship between immunonutrition and fecal microbiota in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of preoperative immunonutrition on fecal microbiota in colon cancer patients: a secondary analysis of a randomized controlled trial. Lee, SY., Lee, J., Park, HM., 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]

Bifidobacteria were present in all samples from patients with diverticulitis and inflammatory bowel disease (IBD), while they were found in 76% of colon cancer samples, suggesting a potential link between bifidobacterial presence and these intestinal diseases.

Patients with diverticulitis had significantly higher levels of specific bifidobacterial species, particularly B. longum and B. animalis, compared to those with colon cancer or IBD, indicating that the composition of the gut microbiota may play a role in the pathogenesis of these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative and quantitative analyses of the bifidobacterial microbiota in the colonic mucosa of patients with colorectal cancer, diverticulitis and inflammatory bowel disease. Gueimonde, M., Ouwehand, A., Huhtinen, H., et al.[2019]

Fecal microbiota transplantation (FMT) showed a clinical remission rate of 30.4% in patients with ulcerative colitis (UC) based on a systematic review of 11 studies involving 133 patients, indicating its potential efficacy in managing the disease.

All studies reported only mild adverse events associated with FMT, suggesting it is a safe intervention; however, more rigorous randomized controlled trials are needed to confirm these findings and establish guidelines for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation as a Novel Therapy for Ulcerative Colitis: A Systematic Review and Meta-Analysis. Sun, D., Li, W., Li, S., et al.[2023]

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]

A new freeze-dried encapsulated preparation of fecal microbiota was developed, allowing for easy and effective fecal microbiota transplantation (FMT) in patients with recurrent Clostridium difficile infection (R-CDI).

In a study involving 49 patients, 88% achieved clinical success with no recurrence of CDI within 2 months, and the treatment led to near normalization of the fecal microbiome within a month, demonstrating the efficacy of this method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Resolution of Recurrent Clostridium difficile Infection using Freeze-Dried, Encapsulated Fecal Microbiota; Pragmatic Cohort Study. Staley, C., Hamilton, MJ., Vaughn, BP., et al.[2022]

In a trial involving 35 patients with active ulcerative colitis, oral lyophilised faecal microbiota transplantation (FMT) led to a significant remission rate, with 53% of patients achieving corticosteroid-free clinical remission compared to 15% in the placebo group.

Continuing FMT after initial treatment resulted in 100% of patients maintaining remission at week 56, suggesting that oral FMT could be a promising long-term treatment option for ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lyophilised oral faecal microbiota transplantation for ulcerative colitis (LOTUS): a randomised, double-blind, placebo-controlled trial. Haifer, C., Paramsothy, S., Kaakoush, NO., et al.[2022]

Fecal microbiota transplantation (FMT) using standardized, frozen fecal microbiota from healthy donors effectively treats recurrent Clostridium difficile infection (CDI), leading to the restoration of gut microbiota structure.

Post-transplant analysis showed significant increases in beneficial bacteria (Firmicutes and Bacteroidetes) in patients, indicating successful engraftment of donor microbiota, while harmful bacteria (Proteobacteria) were reduced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-throughput DNA sequence analysis reveals stable engraftment of gut microbiota following transplantation of previously frozen fecal bacteria. Hamilton, MJ., Weingarden, AR., Unno, T., et al.[2022]

References

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

Donor Screening Experience for Fecal Microbiota Transplantation in Patients With Recurrent C. difficile Infection. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Efficacy and safety of fecal microbiota transplantation for treating patients with ulcerative colitis: A systematic review and meta-analysis. [2021]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of preoperative immunonutrition on fecal microbiota in colon cancer patients: a secondary analysis of a randomized controlled trial. [2023]

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

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

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

Qualitative and quantitative analyses of the bifidobacterial microbiota in the colonic mucosa of patients with colorectal cancer, diverticulitis and inflammatory bowel disease. [2019]

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

Fecal Microbiota Transplantation as a Novel Therapy for Ulcerative Colitis: A Systematic Review and Meta-Analysis. [2023]

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

Successful Resolution of Recurrent Clostridium difficile Infection using Freeze-Dried, Encapsulated Fecal Microbiota; Pragmatic Cohort Study. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Lyophilised oral faecal microbiota transplantation for ulcerative colitis (LOTUS): a randomised, double-blind, placebo-controlled trial. [2022]

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

High-throughput DNA sequence analysis reveals stable engraftment of gut microbiota following transplantation of previously frozen fecal bacteria. [2022]