Testing a new treatment using freeze-dried microbiota for patients undergoing colon surgery
An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection
PHASE1 · University of Minnesota · NCT06692179
This study is testing a new treatment using freeze-dried gut bacteria to see if it can help patients who are having colon surgery feel better and recover more effectively.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, methotrexate, prednisone |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06692179 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial aims to evaluate the safety and feasibility of an orally administered preparation of freeze-dried fecal microbiota (MTP-101P) in patients undergoing colon resection. The study will enroll 40 patients aged 18-75 who are diagnosed with colon polyps, early-stage colorectal cancer, or medically refractory diverticulitis. Participants will receive the investigational product and undergo assessments to evaluate the engraftment of donor microbiota. The findings from this trial will inform future studies on microbiota transplantation in the context of colon and rectal surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 undergoing surgery for unresectable polyps, early-stage colon cancer, or diverticulitis.
Not a fit: Patients with a history of inflammatory bowel disease or those who are pregnant or breastfeeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve recovery outcomes and reduce the risk of recurrent infections in patients undergoing colon surgery.
How similar studies have performed: While this approach is novel, previous studies on microbiota transplantation have shown promising results in related contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able/willing to provide informed consent * Between 18-75 years of age * Undergoing surgery for unresectable polyps, early-stage colon cancer (Stage 1 or 2) not predicted based on pre-operative National Comprehensive Cancer Network guidelines to meet criteria for adjuvant chemotherapy, or a history of diverticulitis. * Able to provide fecal samples. * Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence Exclusion Criteria: * Any history of inflammatory bowel disease * Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child-bearing potential on the proposed day of MTP-101P (prior to its administration). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive MTP-101P. * Life expectancy of \< 6 months * Presence of ileostomy or colostomy * Known history of inflammatory bowel disease (Crohn's, Ulcerative Colitis) * Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors). * Patients with neutropenia (an absolute neutrophil count \<0.5 x 10\^9 cells/L) obtained on a complete blood count with differential at screening. * History of solid organ or bone marrow transplant. * Anticipated recurrent antibiotic use (e.g., patients with frequent urinary tract infections or sinusitis). * History of severe anaphylactic food allergy. * History of celiac disease. * Patients receiving cancer chemotherapy, immunotherapy, or radiation. * Subjects who, in the opinion of the Investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol.
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Cyrus Jahansouz — University of Minnesota
- Study coordinator: Kathryn Vera, PhD
- Email: giero002@umn.edu
- Phone: 612-625-5018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Recurrent Clostridioides Difficile Infection, Colonic Surgery