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Pilot Study of MTP-101P for Colon Surgery Patients

This pilot study is testing a new oral treatment called MTP-101P, which is a freeze-dried preparation of healthy donor microbiota (beneficial bacteria from stool). It's for people aged 18-75 who are having colon surgery for unresectable polyps, early-stage colon cancer (Stage 1 or 2), or diverticulitis. The main goals are to see if MTP-101P is safe and practical to use, and if the donor microbiota successfully "engrafts" (starts living and growing) in your gut. We will also compare your gut bacteria before and after taking MTP-101P. This study is currently recruiting 40 participants.

Study design
This is an open-label, Phase 1 pilot study, meaning both you and the study team will know you are receiving MTP-101P. It will include 40 participants.
What's involved
You will receive MTP-101P 48 hours after intravenous (IV) antibiotics given during your surgery. You will also need to provide fecal samples.
Compensation
Not stated in the trial record.
Follow-up
Your microbiota will be evaluated at 180 days after treatment to see if the donor microbiota has engrafted and how your microbiome has changed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06692179

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
PHASE1Ages 18–75Interventional
University of Minnesota
~40 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Orally administered preparation of fecal microbiota (MTP-101P)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate engraftment of donor microbiota (see 15.3 for statistics) via determination of alpha and beta diversity.
Measured over Day180
+1 more outcome measured

Conditions

Recurrent Clostridioides Difficile Infection
Colonic Surgery

Explore related trials

Colon PolypColorectal CarcinomaDiverticulitis

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Cyrus Jahansouz · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Surgery Clinical Trials Office, MPH
[email protected]
612-624-7463
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Evaluate engraftment of donor microbiota (see 15.3 for statistics) via determination of alpha and beta diversity.Day180

    (via alpha and beta diversity statistics) essentially compares the study patient's microbiome composition at any time point when stool is collected to the microbiome composition of the donor fecal transplant that the study patient receives. Before receiving the fecal transplant, we do not expect the study patient's microbiome composition to mirror the donor. However, after giving the donor fecal transplant, we expect the study patient's microbiome composition to look similar to the transplant they were given.

  • Compare baseline microbiome characteristics with changes over time after MTP-101P.Day180

    In addition to the microbiome compositional statistics we will calculate that are detailed above, we will assess measures of gut health and immune function before and after receiving the fecal transplant. These will be the quantity of short-chain fatty acids in the stool, gut barrier markers in the serum (CD-14, occludin, ZO-1), and overall immune function.