Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Minnesota

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: IMT groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame
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)

Time frame
Day -60-0, Day of surgery, post-op Day1-3, Day14, Day30, Day90, Day180

Secondary outcomes

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

Time frame
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

Time frame
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

Time frame
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

Time frame
Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180

Other outcomes

Sponsors and contacts

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