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Recurrent Clostridioides Difficile InfectionPhase 1NCT06370884

Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection

A Phase 1 study testing IMT in people with Recurrent Clostridioides Difficile Infection and Colonic Surgery, run by University of Minnesota at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
IMT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Feb 2024to 1 Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Surgery Clinical Trials Office contact

612-624-7463

surgcto@umn.edu

United States1 site, 1 recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55414

    Surgery Clinical Trials Office, 612-624-7463, surgcto@umn.edu

    Recruiting

Other trials in United States

About this study

Official title: 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).

Being tested
IMT
Medical subject headings
Clostridium Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMTDrug

    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.

Study groups in NCT06370884
Study groupRoleWhat they receive
IMT groupExperimentalindividuals 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
Receives: Drug: IMT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate safety of IMT in patients undergoing colon surgery

    Collected via adverse event monitoring, to be reported as frequency, relatedness, expectedness, and severity of AEs/SAEs

    Measured: Day of surgery, post-op Day 1-14, Day30, Day60, Day90, Day120, Day150, Day180

  2. compare fecal microbiota prior to and after IMT

    Collected via stool sample collection, to be reported as sequenced microbial DNA profiles (alpha diversity, beta diversity)

    Measured: Day -60-0, Day of surgery, post-op Day1-3, Day14, Day30, Day90, Day180

Secondary outcomes (11)

  1. Evaluate engraftment of donor microbiota

    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

    Measured: Day -60-0, day of surgery, postoperative Day1-3, Day14

  2. Evaluate changes in circulating markers of inflammation: WBC

    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

    Measured: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180

  3. Evaluate changes in circulating markers of inflammation: Hemoglobin

    Collected via blood sample with standard laboratory values reported Hemoglobin is grams/deciliter (g/dL), weight in grams, volume in deciliters

    Measured: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180

  4. Evaluate changes in circulating markers of inflammation: Platelets

    Collected via blood sample with standard laboratory values reported Platelets is 10^9/liter, absolute number in 10^9, volume in liters

    Measured: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180

  5. Evaluate changes in circulating markers of inflammation: Electrolytes

    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

    Measured: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180

  6. Evaluate changes in circulating markers of inflammation

    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

    Measured: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180

  7. Evaluate changes in circulating markers of inflammation: alkaline phosphatase

    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

    Measured: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180

  8. Evaluate changes in circulating markers: Albumin

    Collected via blood sample with standard laboratory values reported Total protein, albumin are grams/liter (g/L) weight in grams, volume in liters

    Measured: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180

  9. Evaluate changes in microbial metabolites: Fecal short-chain fatty-acids

    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

    Measured: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180

  10. Evaluate changes in microbial metabolites: Fecal IgA

    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

    Measured: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180

  11. Compare baseline microbiome characteristics with changes over time after IMT

    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.

    Measured: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2024
  2. Study start1 Feb 2024
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
This is a phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of intestinal microbiota transplantation (IMT) in patients undergoing colon resection.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06370884
Sponsor's protocol ID
SURG-2023-29833
Status last verified
Sep 2026
First submitted
4 Mar 2024
Last updated
3 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMT in people with Recurrent Clostridioides Difficile Infection and Colonic Surgery, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Surgery Clinical Trials Office (612-624-7463, surgcto@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06370884.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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