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Stool Transplantation to Reduce Antibiotic Resistance Transmission

Prospective Observational Study of Fecal Microbiota Transplantation Used to Eradicate Gut-colonizing Multidrug-resistant Bacteria in Patients With Blood Disorders

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02461199
Acronym
START
Enrollment
50
Registered
2015-06-03
Start date
2015-02-28
Completion date
2017-09-30
Last updated
2015-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Disorders

Keywords

Fecal microbiota transplantation, Gut colonization, Multidrug-resistant bacteria, Blood disorders, Drug Resistance, Multiple, Disease Eradication

Brief summary

During this prospective observational study, the investigators collect the information about the outcomes of fecal microbiota transplantation in patients with blood disorders, performed to eradicate gut colonization with multidrug-resistant (MDR) bacteria. Patients with blood disorders are characterized by poor diversity of gut microbiome, affected by repeated chemotherapy and antimicrobial treatments. This makes them vulnerable to colonization by pathogenic bacteria carrying genes responsible for antibiotic resistance. In case of gut mucosa injury and severe immune suppression, these colonizing bacteria may cause severe systemic infections. As the bacteria are secreted with the stool, the colonized patients become an epidemiologic threat to the others. Fecal microbiota transplantation (FMT) was shown to be very efficient in treatment of relapsed and refractory Clostridium difficile infection and became a standard treatment. In home institution, the investigators use FMT not only in case of Clostridium difficile colitis, but also in case of gut colonization with multidrug-resistant (MDR) bacteria. This is based on assumption that physiological gut flora may outcompete the pathogenic bacteria similarly as in case of Clostridium difficile and lead to loss of colonization. The procedure is performed in all patients colonized, who qualify according to listed inclusion and exclusion criteria .

Interventions

BIOLOGICALFecal microbiota transplantation

Transplantation of 100 ml of fecal microbiota suspension obtained from healthy unrelated donor in two consecutive days via the nasoduodenal tube

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>18 y * Carrier status of MDR bacteria in stool: Klebsiella pneumoniae resistant to carbapenems, Pseudomonas aeruginosa resistant to carbapenems, Enterococcus faecalis VRE, Enterococcus faecium VRE, Enterobacter cloacae KPC+ or other MDR species documented by at least two stool cultures * Blood neutrophil count \> 500/uL on the day of fecal microbiota transplantation

Exclusion criteria

* Inability to obtain informed consent and lack of consent * Blood neutrophil count \<500/uL on the day of fecal microbiota transplantation or expected decrease to the mentioned number within 2 consecutive days * Intensive, myelosuppressive chemotherapy (e.g. DHAP, ICE, ESHAP, HD-Cy, HD-Ara-C, DA, conditioning before allogeneic stem cell transplantation, BEACOPP) planned within 2 consecutive days * Patients up to 1 month after hematopoietic stem cell transplantation * Clinical signs of mucositis * Severe liver failure * Patients undergoing intensive antimicrobial treatment

Design outcomes

Primary

MeasureTime frame
Eradication of gut colonizing bacteria as proven by at least two negative stool cultures.2 weeks to 6 months after fecal microbiota transplantation

Secondary

MeasureTime frame
Eradication of gut colonizing bacteria as proven by PCR.2 weeks to 6 months after fecal microbiota transplantation
Incidence of infective episodesfrom day 0 (day of FMT) to 6 months after fecal microbiota transplantation

Countries

Poland

Contacts

Primary ContactJaroslaw Bilinski, MD
jaroslaw.bilinski@gmail.com+48 22 599 29 44
Backup ContactGrzegorz W Basak, MD, PhD
grzegorz.basak@wum.edu.pl+48 22 599 26 40

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026