Clinical trial NCT06370884: Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection
Official title: An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients Undergoing Colon Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Recurrent Clostridioides Difficile Infection
Colonic Surgery
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

Brief 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 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate safety of IMT in patients undergoing colon surgery
timeFrame: Day of surgery, post-op Day 1-14, Day30, Day60, Day90, Day120, Day150, Day180
measure: compare fecal microbiota prior to and after IMT
timeFrame: Day -60-0, Day of surgery, post-op Day1-3, Day14, Day30, Day90, Day180
Secondary outcomes:
measure: Evaluate engraftment of donor microbiota
timeFrame: Day -60-0, day of surgery, postoperative Day1-3, Day14
measure: Evaluate changes in circulating markers of inflammation: WBC
timeFrame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
measure: Evaluate changes in circulating markers of inflammation: Hemoglobin
timeFrame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
measure: Evaluate changes in circulating markers of inflammation: Platelets
timeFrame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
measure: Evaluate changes in circulating markers of inflammation: Electrolytes
timeFrame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
measure: Evaluate changes in circulating markers of inflammation
timeFrame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
measure: Evaluate changes in circulating markers of inflammation: alkaline phosphatase
timeFrame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
measure: Evaluate changes in circulating markers: Albumin
timeFrame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
measure: Evaluate changes in microbial metabolites: Fecal short-chain fatty-acids
timeFrame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
measure: Evaluate changes in microbial metabolites: Fecal IgA
timeFrame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
measure: Compare baseline microbiome characteristics with changes over time after IMT
timeFrame: Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Cyrus Jahansouz, MD
role: PRINCIPAL_INVESTIGATOR
References: