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Impact of exogenous Lactobacillus plantarum on the gut microbiome of hematopoietic stem cell transplantation patients colonized by multi-drug resistant bacteria: An exploratory study

Impact of the use of Lactobacillus plantarum on colonization, infection by multi-resistant bacteria and the microbiome of patients undergoing Hematopoietic Stem Cell Transplantation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2ztbwgr
Enrollment
Unknown
Registered
2021-05-07
Start date
2017-10-30
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Bone Marrow Transplantation, Hematologic Neoplasms

Interventions

L. plantarum, G18 lineage, was administrated as a probiotic to the treatment group (n= 22) at a dose of 5 x 10e9 Colony Forming Units (CFU) twice daily in the form of gastric release capsules produce
G07.203.300.456.500
B03.353.750.450.475.612

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: the presence of oncohematological disease and indication for HSCT; being over 18 years old; not having performed previous gastrointestinal tract surgery; be colonized by antibiotic-resistant bacteria identified by a positive surveillance culture within a maximum of six months before entering the study; and agree to participate in the study after signing the informed consent form.

Exclusion criteria

Exclusion criteria: patient who has agreed to participate in the study, however, has collected fecal material after HSCT; patient with low adherence to therapy (less than 50%).

Design outcomes

Primary

MeasureTime frame
Decolonization by multi-resistant bacteria; Evaluation through the culture of rectal or perianal swab surveillance of participants, previously collected the intervention and weekly during the transplant

Secondary

MeasureTime frame
modulation of the intestinal microbiome; Evaluated through the analysis of intestinal microbiome of stool samples collected weekly (the first before the intervention) until the transplant graft.;Reduction of HSCT infection; assessed by comparing the groups, intervention and control, of infections that occurred during HSCT (medical note).

Countries

Brazil

Contacts

Public ContactBruna Moraes
brudelguerra@yahoo.com.br+5511940813284

Outcome results

None listed

Source: REBEC (via WHO ICTRP)