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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and feasibility of a new oral treatment using fecal microbiota (gut bacteria from healthy donors) for individuals undergoing colon surgery. It targets those with colon polyps, early-stage colorectal cancer, or stubborn diverticulitis (a painful inflammation of the colon). Participants must provide stool samples and be open to follow-up communications. The trial aims to assess how well the treatment helps healthy bacteria settle in the gut, potentially improving recovery after surgery. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this innovative treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that fecal microbiota treatments have been studied for safety in various situations, yielding some promising results. However, specific safety data for MTP-101P, the oral fecal microbiota treatment tested in this trial, is not yet available. Generally, these treatments involve careful donor screening to ensure safety. For instance, one study found that 57% of potential stool donors did not pass initial screenings due to safety concerns, highlighting a thorough process to reduce risks.

This is a Phase 1 trial, primarily focused on assessing the initial safety of the treatment in humans. Phase 1 trials are the first step in testing a new treatment in people, so information on how well the treatment is tolerated is limited. Researchers will closely monitor participants for any side effects. It's important to understand that participating in a Phase 1 trial may involve unknown risks, but it also offers a chance to contribute to medical research at an early stage. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for colon conditions, which often involve surgery and antibiotics, MTP-101P offers a novel approach by using fecal microbiota. This treatment is unique because it harnesses beneficial bacteria to restore a healthy gut environment, potentially reducing the need for more invasive procedures. Researchers are excited about MTP-101P because it could improve recovery times and overall gut health by leveraging the natural balance of microbes, offering a less disruptive alternative to traditional methods.

What evidence suggests that this treatment might be an effective treatment for colon resection?

Research has shown that fecal microbiota transplantation (FMT) can restore a healthy balance of bacteria in the gut. Studies have found that fecal material from healthy donors, in liquid form or as capsules, effectively treats various gut-related issues. Early research suggests that certain bacteria in the stool might predict better outcomes for colorectal cancer patients. In this trial, participants will receive MTP-101P, a new oral version of this treatment, based on proven methods of introducing helpful bacteria to the gut. These beneficial bacteria may improve gut health and support recovery after colon surgery. ^{3 5 6 7 8}

Who Is on the Research Team?

Cyrus Jahansouz

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-1-clostridium-infections-2025-c829e

Fecal Microbiota for Colon Resection Out of 42 potential stool donors screened for fecal microbiota transplantation (FMT), a significant 57% of standard donors failed prescreening due to various ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11547077/

Fecal Microbiota Transplantation: Insights into Colon ... Although the volume of the microbiome is not directly proportional to the amount of stool, it is considered that 60 g of feces are sufficient ...

3. clinicaltrials.gov clinicaltrials.gov/show/NCT06205862

Efficacy and Safety of Fecal Microbiota Transplantation ... We will use fecal suspensions and capsules prepared from the feces of healthy donors for fecal microbiota transplantation. Participants are required to complete ...

4. cghjournal.org cghjournal.org/article/S1542-3565(22)00880-1/fulltext

Effectiveness and Safety of Colonic and Capsule Fecal ... MTP produces a liquid suspension of fecal microbiota separated from stool and cryopreserved with glycerol (MTP-101LR) for colonoscopic delivery ...

5. nature.com nature.com/articles/s41522-025-00702-0

Oral microbiota signature predicts the prognosis of ... Enterotypical Prevotella and three novel bacterial biomarkers in preoperative stool predict the clinical outcome of colorectal cancer.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06692179

Study Details | NCT06692179 | An Open-Label, Pilot ... This Phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of orally administered preparation of fecal microbiota (MTP-101P) in ...

7. trialx.com trialx.com/clinical-trials/listings/304914/an-open-label-pilot-clinical-trial-to-test-the-safety-and-feasibility-of-a-suspension-of-freeze-dried-microbiota-in-patients-undergoing-colon-resection/

An Open-Label, Pilot Clinical Trial To Test The Safety And ... This Phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of orally administered preparation of fecal microbiota ( ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11694295/

Safety and efficacy of faecal microbiota transplantation in ... Each potential donor will go through a thorough and careful screening process including stool analyses for faecal calprotectin, enteric ...