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NCT Number: NCT06370884

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).

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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

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 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.

Treatment and study plan

IMT

Drug

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.

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

Study contacts

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

Surgery Clinical Trials Office

CONTACT

[email protected]

612-624-7463

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 17, 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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