An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Minnesota
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection
