Fecal Microbiota Transplantation for Decolonization of Multidrug-resistant Microorganisms

NCT ID: NCT07265817

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-10-01

Brief Summary

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

Detailed Description

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Conditions

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Carbapenem-Resistant Enterobacteriaceae Colonization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fecal microbiota transplantation group

Group Type ACTIVE_COMPARATOR

Fecal Microbial transplant Capsules

Intervention Type COMBINATION_PRODUCT

3 pills per day for 3 consecutive days with placebo comparatator

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type COMBINATION_PRODUCT

The same amount and shape capsules

Interventions

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Fecal Microbial transplant Capsules

3 pills per day for 3 consecutive days with placebo comparatator

Intervention Type COMBINATION_PRODUCT

Placebo

The same amount and shape capsules

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not provide a consent.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eun Soo Kim, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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KNUH 2023-07-013

Identifier Type: -

Identifier Source: org_study_id

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