Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection

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: Recruiting
• Conditions: Recurrent Clostridioides Difficile Infection; Colonic Surgery
• Intervention / Treatment: Drug: IMT

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kathryn Vera; Phone Number: 612-625-5018; Email: giero002@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Contact: Kathryn Vera, PhD; Phone Number: 612-625-5018; Email: giero002@umn.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	Day of surgery, post-op Day 1-14, Day30, Day60, Day90, Day120, Day150, Day180
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)	Day -60-0, Day of surgery, post-op Day1-3, Day14, Day30, Day90, Day180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day -60-0, day of surgery, postoperative Day1-3, Day14
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	Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
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	Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
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	Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
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	Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
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	Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
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	Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
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	Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
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	Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
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	Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
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.	Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Cyrus Jahansouz, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections
• Other Study ID 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