EP534 - Oral Route of Microbiota Transplantation Therapy Provides Equivalent Engraftment in Colorectal Surgery Patients

ePoster Presenter(s)

• 

  Julia Frebault, MD (she/her/hers)

  General Surgery Research Resident
  University of Minnesota
  University of Minnesota
  Minneapolis, MN, United States

  Disclosure information not submitted.

Author(s)

• MH

  Max G. Hill, BS

  Research Assistant
  UMN Department of Surgery
  St. Paul, Minnesota, United States

  Disclosure information not submitted.
• 

  Alexander M. Troester, MD (he/him/his)

  General Surgery Resident
  University of Minnesota
  University of Minnesota
  Minneapolis, MN, United States

  Disclosure information not submitted.
• CB

  Catherine Beauharnais, MD, MPH, MS

  Fellow
  University of Minnesota
  University of Minnesota
  Minneapolis, MN, United States

  Disclosure information not submitted.
• SB

  Sonja Boatman, MD (she/her/hers)

  Resident
  Universit of Minnesota
  University of Minnesota
  Minneapolis, MN, United States

  All of the relevant financial relationships listed below have been mitigated.
  This individual has no financial relationships with ineligible companies.
• 

  Paolo Goffredo, MD (he/him/his)

  Assistant Professor
  University of Minnesota
  Minneapolis, MN, United States

  All of the relevant financial relationships listed below have been mitigated.
  This individual has no financial relationships with ineligible companies.
• 

  Wolfgang Gaertner, MD, MSc, MBA

  Professor and Chief, Colon & Rectal Surgery
  University of Minnesota
  University of Minnesota
  Minneapolis, MN, United States

  All of the relevant financial relationships listed below have been mitigated.
  This individual has no relevant relationships with ineligible companies.
• CS

  Christopher Staley, n/a

  Associate Professor
  University of Minnesota
  Minneapolis, Minnesota, United States

  Disclosure information not submitted.

Senior Author(s)

• 

  Cyrus Jahansouz, MD

  Assistant Professor
  University of Minnesota
  University of Minnesota
  Minneapolis, Minnesota, United States

  All of the relevant financial relationships listed below have been mitigated.
  This individual has no financial relationships with ineligible companies.

Purpose/Background: The combination of surgical bowel preparation (SBP) and colon resection depletes commensal gut microbiota and allows for expansion of pathogenic taxa, which have been linked to postoperative complications including anastomotic leak, surgical site infection, and delayed return of bowel function. Microbiota transplantation therapy (MTT) of purified fecal microbiota from healthy donors has emerged as a promising therapy for restoring gut microbiota and its essential functions. However, an optimal route of delivery balancing efficacy with ease of administration, has not been identified. This pilot clinical trial examined the efficacy of oral versus nasojejunal tube (NJT) delivery of MTT in patients undergoing colorectal surgery.

Methods/Interventions: Seventeen patients underwent sigmoidectomy for cancer or diverticular disease and received MTT in the acute postoperative period (12 via NJT formulation [IND 28152] and 5 via oral formulation [IND 30860]). All patients received SBP (mechanical bowel preparation with oral Neomycin and Metronidazole) with standard perioperative parenteral antibiotic prophylaxis up to 24hrs postoperatively. Fecal samples were collected pre-operatively, within 24 hours after transplantation (inpatient), postoperative day (POD)14, and POD30, with sampling extended to POD90 and POD180 in the NJT group. MTT was performed on POD2-3. SourceTracker assessed the similarity of postoperative composition to donors as well as to patients' own preoperative microbiota. Groups were compared using ANOVA and Kruskal-Wallis methods.

Results/Outcomes: All patients received MTT without complication. Inpatient samples had 19.7% and 19.1% similarity to donor in the NJT and oral groups, respectively, rising to 55.5% vs. 48.4% at POD14 and 56.7% vs. 51.5% at POD30, respectively. Extended sampling in the NJT group showed durable engraftment through POD180 (Figure 1). There was no statistically significant differences in engraftment between groups at any timepoint (P=0.94, 1.00, and 0.93 for inpatient, POD14, and POD30, respectively).

Conclusion/Discussion: In this series comparing efficacy of MTT after colorectal surgery via NJT and oral formulations, similar engraftment was observed in each group, demonstrating reliable reconstitution of fecal microbiota following colon resection. While further evaluation with a larger cohort and prolonged sampling is warranted, a reliable MTT formulation with ease of use is a promising avenue for addressing microbial dysbiosis following colorectal surgery.

Figure 1
Comparison of engraftment assessed as the percentage similarity between fecal microbiota of transplanted patients to that of healthy donors in patients administered MTT via nasojejunal tube (NJT) and oral route (Oral).