NCT07265817

Brief Summary

The aim of the study is to see whether fecal microbiota transplantation is effective to decolonize multidrug-resistant organisms.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Dec 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Dec 2025Oct 2027

First Submitted

Initial submission to the registry

November 24, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

November 24, 2025

Last Update Submit

November 24, 2025

Conditions

Carbapenem-Resistant Enterobacteriaceae Colonization

Outcome Measures

Primary Outcomes (1)

  • Conversion to negative organism

    1 year

Study Arms (2)

Fecal microbiota transplantation group

ACTIVE COMPARATOR
Combination Product: Fecal Microbial transplant Capsules

Placebo

PLACEBO COMPARATOR
Combination Product: Placebo

Interventions

Fecal Microbial transplant CapsulesCOMBINATION_PRODUCT

3 pills per day for 3 consecutive days with placebo comparatator

Fecal microbiota transplantation group
PlaceboCOMBINATION_PRODUCT

The same amount and shape capsules

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have positive results in PCR or culture of rectal swab.

You may not qualify if:

  • Not provide a consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 5, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

December 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share