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.
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
- Conditions the study is for
- Recurrent Clostridioides Difficile Infection, Colonic Surgery
- 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
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.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Surgery Clinical Trials Office, 612-624-7463, surgcto@umn.edu
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 group | Role | What they receive |
|---|---|---|
| IMT group | Experimental | 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 Receives: Drug: IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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
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
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
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
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
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
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
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
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.
- First posted17 Apr 2024
- Study start1 Feb 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Clostridioides Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyrus Jahansouz, MD, Principal investigator, University of Minnesota
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