RECRUITING

An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection

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Conditions

Recurrent Clostridioides Difficile InfectionColonic Surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection

Quick Facts

Study Start:2025-02-18
Study Completion:2027-02-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06692179

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able/willing to provide informed consent
  2. * Between 18-75 years of age
  3. * 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.
  4. * Able to provide fecal samples.
  5. * 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
  1. * Any history of inflammatory bowel disease
  2. * 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.
  3. * Life expectancy of \< 6 months
  4. * Presence of ileostomy or colostomy
  5. * Known history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
  6. * Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).
  7. * Patients with neutropenia (an absolute neutrophil count \<0.5 x 10\^9 cells/L) obtained on a complete blood count with differential at screening.
  8. * History of solid organ or bone marrow transplant.
  9. * Anticipated recurrent antibiotic use (e.g., patients with frequent urinary tract infections or sinusitis).
  10. * History of severe anaphylactic food allergy.
  11. * History of celiac disease.
  12. * Patients receiving cancer chemotherapy, immunotherapy, or radiation.
  13. * 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.

Contacts and Locations

Study Contact

Kathryn Vera, PhD
CONTACT
612-625-5018
giero002@umn.edu

Principal Investigator

Cyrus Jahansouz
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Cyrus Jahansouz, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-18
Study Completion Date2027-02-18

Study Record Updates

Study Start Date2025-02-18
Study Completion Date2027-02-18

Terms related to this study

Additional Relevant MeSH Terms

  • Recurrent Clostridioides Difficile Infection
  • Colonic Surgery