Pilot Study to Test Safety and Feasibility of Oral Freeze-Dried Microbiota in Adults Undergoing Colon Surgery for Polyps, Early Colon Cancer, or Diverticulitis

What this Trial Is About

Researchers are conducting a Phase 1 pilot clinical trial to evaluate the initial safety and feasibility of an oral preparation of fecal microbiota called MTP-101P in patients undergoing colon resection. The study involves male and female patients aged 18 to 75 years diagnosed with colon polyps, early-stage colorectal cancer stage I or II, or medically refractory diverticulitis. The trial aims to inform future treatments related to colon and rectal surgery and includes a limited evaluation of how donor microbiota engrafts in patients. Participants will receive the investigational drug MTP-101P, which is a highly purified, freeze-dried fecal microbiota suspension from healthy donors. Before surgery, patients will receive mechanical bowel preparation and oral antibiotics as standard care, along with intravenous antibiotics at surgery. MTP-101P will be administered 48 hours after IV antibiotics to avoid interference from antibiotics on the microbiota. A total of 40 patients will receive the study drug. Throughout the trial, participants will provide fecal samples to assess the engraftment of donor microbiota and changes in their microbiome over time, with some stool samples possibly returned by mail. Researchers will measure microbiome diversity and compare baseline and post-treatment microbiome characteristics over 180 days. Participants will be followed up through telephone, in-person, email, or video visits to monitor safety and study outcomes, with the study scheduled to complete in 2027.

An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection