Microbiota Transplant for Colon Resection

Overseen By Kathryn Vera

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)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

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 Intestinal Microbiota Transplantation (IMT) for individuals undergoing colon surgery. The goal is to determine if introducing healthy gut bacteria through a feeding tube can be safely performed after surgery for conditions like diverticulitis or sigmoid colon cancer. The trial seeks participants who have these conditions and are scheduled for surgery. Participants must also provide stool samples and agree to follow-up with the research team after the procedure. As a Phase 1 trial, the research focuses on understanding how the treatment works 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, you would not be eligible to participate.

Is there any evidence suggesting that Intestinal Microbiota Transplantation is likely to be safe for humans?

Research has shown that fecal microbiota transplantation (FMT) is generally safe and well-tolerated. FMT involves transferring healthy bacteria from one person's gut to another's to help balance gut bacteria. This method has treated conditions like ulcerative colitis and can also improve cancer treatment outcomes.

Past research indicates that FMT has a good safety record. Most side effects are mild and temporary, such as stomach upset or diarrhea, and serious side effects are rare. While researchers continue to study FMT for new uses, its current safety record is promising. This evidence suggests that a similar procedure, intestinal microbiota transplantation, might also be safe for people undergoing colon surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for conditions like diverticulitis or sigmoid colon cancer, which often involve antibiotics or surgery, Intestinal Microbiota Transplantation (IMT) is unique because it focuses on restoring a healthy balance of gut bacteria. Researchers are excited about this approach because it uses beneficial microbes to potentially improve gut health and enhance recovery after colon resection surgery. This method offers a novel mechanism of action by directly altering the gut microbiome, which could lead to better outcomes and fewer complications compared to traditional options.

What evidence suggests that Intestinal Microbiota Transplantation might be an effective treatment for patients undergoing colonic surgery?

Research suggests that Intestinal Microbiota Transplantation (IMT), which participants in this trial may receive, might benefit those undergoing colon surgery, such as individuals with diverticulitis or colon cancer. Studies have shown that IMT, similar to Fecal Microbiota Transplantation (FMT), can restore gut bacteria balance, potentially aiding recovery and strengthening the immune system. This method has been explored in cancer treatments and shows promise in reducing treatment side effects. Patients who received similar treatments experienced improved gut health and fewer symptoms in conditions like ulcerative colitis. Although more research is needed, these early results indicate that IMT could support recovery after colon surgery. ^{1 2 4 5 6}

Who Is on the Research Team?

Cyrus Jahansouz, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who have had diverticulitis and are undergoing colon resection surgery. Participants will receive either an intestinal microbiota transplant (IMT) or a saline solution through a feeding tube after surgery. They must meet certain health criteria, not be allergic to the materials used, and agree to follow-up assessments.

Inclusion Criteria

I am willing and able to follow all study requirements and stay in touch as needed.

Able/willing to provide informed consent

I am having surgery due to past diverticulitis issues.

Exclusion Criteria

I have had a solid organ or bone marrow transplant.

I have an ileostomy or colostomy.

I have been diagnosed with celiac disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery and IMT Administration

Participants undergo colon resection surgery and receive IMT solution via nasogastric feeding tube on postoperative day 2-3

1 week

In-patient monitoring

Immediate Postoperative Follow-up

Participants are monitored for safety and effectiveness, including adverse events, from discharge through post-operative day 14

2 weeks

Follow-up by phone, video, in-person, or online survey

Long-term Follow-up

Participants are monitored monthly up to 6 months post-IMT for safety and changes in microbiome

6 months

Monthly follow-up by phone, video, in-person, or online survey

What Are the Treatments Tested in This Trial?

Interventions

• Intestinal Microbiota Transplantation

Trial Overview The study tests the safety of delivering IMT via a nasogastric feeding tube compared to a saline solution in patients post-colon surgery. It aims to see if this method is feasible without causing harm like bowel perforation or disrupting the surgical site.

How Is the Trial Designed?

Group I: IMT group Experimental Treatment 1 Intervention

individuals of the ages of 18-75 with a history of diverticulitis or sigmoid colon cancer will be enrolled to have a feeding tube placed at the time of surgery and receive either IMT solution

Intestinal Microbiota Transplantation is already approved in United States, European Union 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

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Fecal microbiota transplantation (FMT) is an effective method for restoring healthy gut flora in patients suffering from Clostridium difficile infection (CDI).

There is a need for further research to understand how FMT can be safely and effectively used in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in patients with cancer undergoing treatment. Blackburn, LM., Bales, A., Caldwell, M., et al.[2020]

Fecal microbiota transplantation (FMT) is an effective treatment for restoring healthy gut bacteria in patients with disrupted intestinal microbiota, particularly in conditions like Clostridium difficile infection.

The review emphasizes the importance of careful donor selection and proper processing and storage of fecal material to ensure the safety and efficacy of the transplantation procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fecal microbiota transplantation: donor selection criteria, storage and preparation of biomaterials (review of current recommendations)]. Iakupova, AA., Abdulkhakov, SR., Safin, AG., 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]

Fecal microbiota transplantation (FMT) has a reported adverse event (AE) rate of 39.3%, primarily involving mild and self-limiting issues like abdominal pain and diarrhea, based on a meta-analysis of 9 high-quality studies involving 756 FMTs.

Serious adverse events (SAE) were relatively rare at 5.3%, with the most common being Clostridium difficile infection, indicating that while FMT is generally safe, monitoring and standardized reporting are essential for understanding its long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of fecal microbiota transplantation: a meta-analysis of high-quality studies. Michailidis, L., Currier, AC., Le, M., et al.[2022]

Fecal microbiota transplantation (FMT) is a generally safe and well-tolerated procedure for treating recurrent Clostridioides difficile infections, even in high-risk patients, with most short-term risks being mild and related to delivery methods.

Recent concerns have emerged regarding serious adverse events linked to FMT products from stool banks that do not screen for multi-drug resistant organisms, highlighting the need for improved safety protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation: Is It Safe? Park, SY., Seo, GS.[2021]

Fecal microbiota transplantation (FMT) is primarily effective for treating recurrent Clostridium difficile infections by restoring a healthy microbiome in the colon.

Currently, there is not enough evidence to support the use of FMT for other gastrointestinal or nongastrointestinal diseases, although research is ongoing in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation. Vindigni, SM., Surawicz, CM.[2020]

Fecal microbiota transplant (FMT) is an effective treatment for recurrent Clostridioides difficile infections, highlighting its established role in restoring gut health.

There is growing interest in exploring FMT's potential benefits for other gastrointestinal diseases linked to dysbiosis, suggesting it may have broader therapeutic applications beyond just C. difficile infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplant, its usefulness beyond Clostridioides difficile in gastrointestinal diseases. Núñez F, P., Quera, R., Bay, C., et al.[2022]

In a follow-up study of 77 IBS patients who previously responded to fecal microbiota transplantation (FMT), 86.5% of those receiving 30-g and 87.5% of those receiving 60-g FMT maintained their positive response after 1 year.

Improvements in abdominal symptoms and quality of life continued to increase over the year, alongside significant changes in the fecal bacterial profile and levels of short-chain fatty acids, indicating the long-term efficacy and safety of FMT for IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of fecal microbiota transplantation (FMT) in patients with irritable bowel syndrome. El-Salhy, M., Kristoffersen, AB., Valeur, J., et al.[2022]

Faecal microbiota transplantation (FMT) has proven effective for treating recurrent Clostridium difficile infections, with established protocols and donor stool banks in Denmark.

However, FMT is not recommended for routine use in treating inflammatory bowel disease or irritable bowel syndrome due to insufficient clinical trial data supporting its efficacy for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Faecal microbiota transplantation for the treatment of bowel disease]. Rode, AA., Chehri, M., Petersen, AM., et al.[2019]

Fecal microbiota transplantation (FMT) showed significant long-term efficacy in reducing IBS symptoms, with response rates of 69.1% and 77.8% for the 30g and 60g treatment groups, respectively, at 2 years, and 64.9% and 71.8% at 3 years, compared to only 26.3% in the placebo group.

No long-term adverse events were reported, indicating that FMT is a safe intervention for IBS, with improvements in quality of life and a decrease in dysbiosis index observed in the treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. El-Salhy, M., Winkel, R., Casen, C., et al.[2022]

Fecal microbiota transplantation (FMT) has proven to be highly effective in treating recurrent and refractory Clostridioides difficile infections (CDI), leading to a surge in research on gut microbiota therapies.

The future of microbiome-based treatments is expected to focus on developing oral formulations with known ingredients, clear mechanisms of action, and strong safety profiles, expanding the potential applications of FMT beyond CDI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expert opinion on fecal microbiota transplantation for the treatment of Clostridioides difficile infection and beyond. Kumar, V., Fischer, M.[2020]

Fecal microbiota transplantation (FMT) effectively normalizes the gut microbiota in patients with recurrent Clostridium difficile infection, showing significant changes within just one day after the procedure.

While the microbiota composition initially resembles that of the donor, it diverges over time, indicating that the gut microbiome is dynamic and requires ongoing monitoring to evaluate the long-term success of FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic changes in short- and long-term bacterial composition following fecal microbiota transplantation for recurrent Clostridium difficile infection. Weingarden, A., González, A., Vázquez-Baeza, Y., et al.[2018]

Citations

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Fecal Microbiota Transplantation: Insights into Colon ... Fecal microbiota transplantation (FMT) has emerged as a compelling therapeutic approach, offering the potential to modulate microbial ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06370884

Intestinal Microbiota Transplantation in Patients ... Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection ... compare fecal microbiota prior to and after IMT, Collected via stool sample ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0305737225001471

Fecal microbiota transplantation to enhance cancer ... This systematic review evaluates Fecal Microbiota Transplantation (FMT)'s impact on cancer treatment outcomes and treatment-related toxicity and explores its ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11915259/

Therapeutic potential of fecal microbiota transplantation in ... Fecal microbiota transplantation (FMT) restores balance and boosts immunity, offering promise for personalized CRC therapies with further clinical validation.

5. nature.com nature.com/articles/s41598-023-41182-6

Efficacy and safety of fecal microbiota transplantation in the ... Fecal microbiota transplantation has shown potential as a therapeutic intervention for inducing clinical remission in ulcerative colitis UC.

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

Safety and efficacy of faecal microbiota transplantation in ... ... stool bank for fecal microbiota transplantation within the blood- and tissue transplant service? ... safety of fecal microbiota transplant ...