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Tests treatment safety and results for Recurrent Clostridioides Difficile Infection
Official title An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection
ClinicalTrials.gov ID: NCT06692179
What this study is testing
What is Orally administered preparation of fecal microbiota (MTP-101P)?
Orally administered preparation of fecal microbiota (MTP-101P) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent clostridioides difficile infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- 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...
You likely can't join 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...
- 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...
See the full eligibility criteria
- 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...
- 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
- 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...
- 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.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.