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NCT Number: 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

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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Key information

Conditions

Recurrent Clostridioides Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Colonic Surgery Gram-Positive Bacterial Infections Infections

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Surgery Clinical Trials Office, MPH

CONTACT

[email protected]

612-624-7463

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orally administered preparation of fecal microbiota (MTP-101P)

Drug

As per standard of care, patients will receive MBP and OA the day prior to surgery as well as IV antibiotics at the time of surgery. MTP-101P will be given 48 hours after the administration of the dose of IV antibiotics to avoid the undesired bactericidal effects of antibiotics on the bacterial load from MTP-101P.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Surgery Clinical Trials Office, MPH

CONTACT

[email protected]

612-624-7463

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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