Recurrent Clostridioides Difficile InfectionPhase 1NCT06692179
An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection
A Phase 1 study testing Orally administered preparation of fecal microbiota (MTP-101P) in people with Recurrent Clostridioides Difficile Infection and Colonic Surgery, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Clostridioides Difficile Infection, Colonic Surgery
- What is being tested?
- Orally administered preparation of fecal microbiota (MTP-101P)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2025to 8 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
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.
- Being tested
- Orally administered preparation of fecal microbiota (MTP-101P)
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orally administered preparation of fecal microbiota (MTP-101P)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Male and female patients, ages 18-75, diagnosed with colon polyps or early (stage I or II) colorectal cancer or medically refractory diverticulitis. Receives: Drug: Orally administered preparation of fecal microbiota (MTP-101P) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate engraftment of donor microbiota (see 15.3 for statistics) via determination of alpha and beta diversity.
(via alpha and beta diversity statistics) essentially compares the study patient's microbiome composition at any time point when stool is collected to the microbiome composition of the donor fecal transplant that the study patient receives. Before receiving the fecal transplant, we do not expect the study patient's microbiome composition to mirror the donor. However, after giving the donor fecal transplant, we expect the study patient's microbiome composition to look similar to the transplant they were given.
Measured: Day180
Compare baseline microbiome characteristics with changes over time after MTP-101P.
In addition to the microbiome compositional statistics we will calculate that are detailed above, we will assess measures of gut health and immune function before and after receiving the fecal transplant. These will be the quantity of short-chain fatty acids in the stool, gut barrier markers in the serum (CD-14, occludin, ZO-1), and overall immune function.
Measured: Day180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start18 Feb 2025
- Primary completion8 Jun 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Clostridioides Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyrus Jahansouz, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692179
- Sponsor's protocol ID
- Freeze-dried Microbiota
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- Freeze-dried Microbiota
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Orally administered preparation of fecal microbiota (MTP-101P)Male and female patients, ages 18-75, diagnosed with colon polyps or early (stage I or II) colorectal cancer or medically refractory diverticulitis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Experimental group |
Primary outcome
Evaluate engraftment of donor microbiota (see 15.3 for statistics) via determination of alpha and beta diversity.
Time frame: Day180
(via alpha and beta diversity statistics) essentially compares the study patient's microbiome composition at any time point when stool is collected to the microbiome composition of the donor fecal transplant that the study patient receives. Before receiving the fecal transplant, we do not expect the study patient's microbiome composition to mirror the donor. However, after giving the donor fecal transplant, we expect the study patient's microbiome composition to look similar to the transplant they were given.
Compare baseline microbiome characteristics with changes over time after MTP-101P.
Time frame: Day180
In addition to the microbiome compositional statistics we will calculate that are detailed above, we will assess measures of gut health and immune function before and after receiving the fecal transplant. These will be the quantity of short-chain fatty acids in the stool, gut barrier markers in the serum (CD-14, occludin, ZO-1), and overall immune function.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyrus Jahansouz principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Orally administered preparation of fecal microbiota (MTP-101P) in people with Recurrent Clostridioides Difficile Infection and Colonic Surgery, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate engraftment of donor microbiota (see 15.3 for statistics) via determination of alpha and beta diversity. (time frame: Day180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.