Poop pills could protect gut after colon surgery – early trial begins
NCT ID NCT06692179
First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This early-stage trial is testing whether a pill made from freeze-dried healthy donor stool (MTP-101P) is safe and can restore good bacteria in people having part of their colon removed. Forty adults aged 18-75 with colon polyps, early-stage cancer, or diverticulitis will take the pill after surgery. Researchers will check if the donor bacteria take hold and improve gut health markers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- freeze-dried fecal microbiota (MTP-101P)
- What this could lead to
- If successful, this could pave the way for a simple pill to restore healthy gut bacteria after colon surgery, potentially reducing infections like C. diff.
- What could go wrong
- This is a very early Phase 1 trial with only 40 people, so safety and effectiveness are not yet proven. The treatment may not work or could cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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21 people
The number who actually took part.
- Started
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Feb 2025
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 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 Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Minnesota
Minneapolis, Minnesota, 55414, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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