An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection
Recruiting
Phase 1Interventional Study
Recurrent Clostridioides Difficile InfectionColonic Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
40 (estimated)
Sponsor
University of Minnesota · Other
Who this trial is looking for
This trial is looking for adults aged 18-75 who are having surgery for colon polyps, early-stage colon cancer, or diverticulitis. Participants will take a new treatment made from healthy fecal microbiota to see if it's safe and effective.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18-75 years old.
I am having surgery for colon polyps, early-stage colon cancer, or diverticulitis.
I am willing to provide informed consent.
I can provide stool samples.
I agree to follow all study procedures.
I am available for follow-up during the trial.
You may not be able to join if
I have a history of inflammatory bowel disease.
I am pregnant or breastfeeding.
My life expectancy is less than 6 months.
I have a colostomy or ileostomy.
I take immunosuppressant medications.
I have had a solid organ or bone marrow transplant.
I have a severe food allergy or celiac disease.
I am currently receiving cancer treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 re…
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). Stool samples may be returned via mail rather than clinic visit.
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Eligibility 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 chemo…
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.
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