Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection

September 2, 2026 updated by: University of Minnesota

An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients Undergoing Colon Resection

This is a single-center, open-label study for safety and feasibility of IMT in patients undergoing colonic surgery. After consent, individuals of the ages of 18-75 with a history of diverticulitis or sigmoid colon cancer will be enrolled to have a feeding tube placed at the time of surgery and receive IMT solution on postoperative day 2-3 (at least 48 hours following IV antibiotics) with the subsequent removal of the feeding tube. Prior to administration of IMT, recipients will be screened for inclusion/exclusion criteria, interviewed for medical history and medications, and consented. Additionally, prior to undergoing IMT, baseline blood and fecal samples will be collected. The use of a nasogastric feeding tube has specifically been chosen over colonoscopic introduction of the IMT. This is because colonoscopy introduces increased intraluminal carbon dioxide and pressure as well as mechanical stress on the colon in the setting of a newly created bowel anastomosis, which may contribute to the potential risk of anastomotic disruption. The nasogastric feeding tube will be placed while the patient is under anesthesia under direct visualization to minimize any risk of bowel perforation, albeit very low. The study will specifically utilize a 10F 43" Corpak feeding tube (Halyard Health, Alpharetta, GA). Patients will be monitored while in-patient in person. Following discharge, they will undergo follow-up either by phone, video or in-person visit, or via online survey of symptoms and chronic medical conditions potentially related to IMT, beginning on the day following discharge through post-operative day 14, and then monthly up to 6 months post- IMT to screen for SAEs and AEs. Screening for SAEs and AEs will be done using a symptom questionnaire as well as by asking patients during our interview. Fecal samples will be collected from participants on months one, three and six post-IMT to assess for changes in recipient microbiome (engraftment kinetics).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Surgery Clinical Trials Office
  • Phone Number: 612-624-7463
  • Email: surgcto@umn.edu

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • Recruiting
        • University of Minnesota
        • Contact:
          • Surgery Clinical Trials Office
          • Phone Number: 612-624-7463
          • Email: surgcto@umn.edu

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Able/willing to provide informed consent
  • Between 18-75 years of age
  • Undergoing surgery for a history of diverticulitis or sigmoid colon cancer.
  • 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 IMT (prior to the receipt of IMT). 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 IMT treatment.
  • 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 109 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IMT group
individuals of the ages of 18-75 with a history of diverticulitis or sigmoid colon cancer will be enrolled to have a feeding tube placed at the time of surgery and receive either IMT solution
Drug: IMT
a feeding tube placed at the time of surgery and receive IMT solution on postoperative day 2-3 (at least 48 hours following IV antibiotics) with the subsequent removal of the feeding tube.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate safety of IMT in patients undergoing colon surgery
Time Frame: Day of surgery, post-op Day 1-14, Day30, Day60, Day90, Day120, Day150, Day180
Collected via adverse event monitoring, to be reported as frequency, relatedness, expectedness, and severity of AEs/SAEs
Day of surgery, post-op Day 1-14, Day30, Day60, Day90, Day120, Day150, Day180
compare fecal microbiota prior to and after IMT
Time Frame: Day -60-0, Day of surgery, post-op Day1-3, Day14, Day30, Day90, Day180
Collected via stool sample collection, to be reported as sequenced microbial DNA profiles (alpha diversity, beta diversity)
Day -60-0, Day of surgery, post-op Day1-3, Day14, Day30, Day90, Day180

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate engraftment of donor microbiota
Time Frame: Day -60-0, day of surgery, postoperative Day1-3, Day14
ollected via stool sample, to be reported as sequenced microbial DNA profiles (alpha diversity, beta diversity). We will compare preoperative stool samples to samples collected post-transplant of the donor microbiota
Day -60-0, day of surgery, postoperative Day1-3, Day14
Evaluate changes in circulating markers of inflammation: WBC
Time Frame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Collected via blood sample with standard laboratory values reported White blood count (WBC) is 10^9/liter, absolute number in 10^9, volume in liters
Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Evaluate changes in circulating markers of inflammation: Hemoglobin
Time Frame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Collected via blood sample with standard laboratory values reported Hemoglobin is grams/deciliter (g/dL), weight in grams, volume in deciliters
Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Evaluate changes in circulating markers of inflammation: Platelets
Time Frame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Collected via blood sample with standard laboratory values reported Platelets is 10^9/liter, absolute number in 10^9, volume in liters
Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Evaluate changes in circulating markers of inflammation: Electrolytes
Time Frame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Collected via blood sample with standard laboratory values reported Sodium, potassium, chloride, carbon dioxide are millimole/liter (mmol/L), amount of substance in millimoles, volume in liters
Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Evaluate changes in circulating markers of inflammation
Time Frame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Collected via blood sample with standard laboratory values reported Blood urea nitrogen, creatinine, glucose, magnesium, total bilirubin, prealbumin are milligrams/deciliter (mg/dL) weight in milligrams, volume in deciliters
Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Evaluate changes in circulating markers of inflammation: alkaline phosphatase
Time Frame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Collected via blood sample with standard laboratory values reported Alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine transaminase (ALT) are units/liter (U/L) amount of substance in Units, volume in liters
Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Evaluate changes in circulating markers: Albumin
Time Frame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Collected via blood sample with standard laboratory values reported Total protein, albumin are grams/liter (g/L) weight in grams, volume in liters
Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Evaluate changes in microbial metabolites: Fecal short-chain fatty-acids
Time Frame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Collected via blood sample with standard laboratory values reported Fecal short-chain fatty acids are millimole/kilogram (mmol/kg) amount of substance in millimoles, weight in kilograms
Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Evaluate changes in microbial metabolites: Fecal IgA
Time Frame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Collected via blood sample with standard laboratory values reported Fecal IgA is nanograms IgA/ milligram of stool (ng IgA/mg stool) weight of IgA in nanograms, weight of stool in milligrams
Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Compare baseline microbiome characteristics with changes over time after IMT
Time Frame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Collected via stool sample, to be reported as sequenced microbial DNA profiles (alpha diversity, beta diversity). We will compare preoperative stool samples to samples collected post-transplant of the donor microbiota across all time points.
Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cyrus Jahansouz, MD, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SURG-2023-29833

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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