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

Обзор

This Phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of orally administered preparation of fecal microbiota (MTP-101P) in patients undergoing colon resection. We plan to enroll male and female patients, ages 18-75, diagnosed with colon polyps or early (stage I or II) colorectal cancer or medically refractory diverticulitis. We will recruit 40 patients total to receive the investigational product. This trial will inform development of future trials in treatment of colon and rectal surgery. Active drug is composed of highly purified, freeze-dried, fecal microbiota from healthy donors. This study will also allow for limited evaluation of pharmacokinetics in terms of donor microbiota engraftment. The exploratory objective is to evaluate engraftment of donor microbiota with this preparation and compare the results with data generated with the data generally from microbiota transplantation (IND28152). Stool samples may be returned via mail rather than clinic visit.

Вмешательства

• Препарат Orally administered preparation of fecal microbiota (MTP-101P)
  As per standard of care, patients will receive MBP and OA the day prior to surgery as well as IV antibiotics at the time of surgery. MTP-101P will be given 48 hours after the administration of the dose of IV antibiotics to avoid the undesired bactericidal effects of antibiotics on the bacterial load from MTP-101P.

Первичные конечные точки

• Evaluate engraftment of donor microbiota (see 15.3 for statistics) via determination of alpha and beta diversity. [Срок оценки: Day180]
• Compare baseline microbiome characteristics with changes over time after MTP-101P. [Срок оценки: Day180]

Критерии участия

Критерии включения

• Able/willing to provide informed consent
• Between 18-75 years of age
• Undergoing surgery for unresectable polyps, early-stage colon cancer (Stage 1 or 2) not predicted based on pre-operative National Comprehensive Cancer Network guidelines to meet criteria for adjuvant chemotherapy, or a history of diverticulitis.
• 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

Критерии исключения

• 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 MTP-101P (prior to its administration). 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 MTP-101P.
• 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 10\^9 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.
• Subjects who, in the opinion of the Investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of Minnesota — Minneapolis

Идентификаторы

NCT: NCT06692179 · Freeze-dried Microbiota

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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