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NCT06692179
An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection
Phase 1 trial testing Orally administered preparation of fecal microbiota (MTP-101P) in Recurrent Clostridioides Difficile Infection in 40 participants. Currently enrolling.
18 February 2027
Quick facts
| Lead sponsor | University of Minnesota |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 40 |
| Start date | 18 February 2025 |
| Primary completion | 18 February 2027 |
| Estimated completion | 18 February 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Orally administered preparation of fecal microbiota (MTP-101P) — full drug profile →
Conditions studied
- Recurrent Clostridioides Difficile Infection — all drugs for Recurrent Clostridioides Difficile Infection →
- Colonic Surgery — all drugs for Colonic Surgery →
Sponsor
University of Minnesota
Who can join
Adults 18 to 75, any sex, with Recurrent Clostridioides Difficile Infection or Colonic Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06692179
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other recruiting trials for Recurrent Clostridioides Difficile Infection
Currently open trials in the same condition.
- NCT06370884 — Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection · Phase 1 · recruiting
Other University of Minnesota trials
Trials by the same sponsor.
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- NCT04100109 — Evaluating the Metabolic Effects of Polylactose: A Novel Prebiotic · NA · withdrawn
- NCT05454306 — Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures · NA · withdrawn
- NCT03192007 — Multi-Parametric MRI for Renal Transplantation · not yet recruiting
- NCT04940533 — Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06692179 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Minnesota
- Last refreshed: 22 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06692179.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing