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Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy

Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03728699
Enrollment
54
Registered
2018-11-02
Start date
2018-01-02
Completion date
2022-02-18
Last updated
2023-11-03

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

Conditions

Acute Myeloid Leukemia

Keywords

AML

Brief summary

This is a prospective, observational study to collect stool and blood from acute myeloid leukemia patients undergoing intensive chemotherapy.

Interventions

DIAGNOSTIC_TESTSample Collection Blood

Collected from each patient twice weekly.

DIAGNOSTIC_TESTStool Sample

Collected from each patient twice weekly.

Sponsors

Masonic Cancer Center, University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Adults (ages 18 - 99 years) undergoing inpatient intensive chemotherapy for newly diagnosed, refractory, or relapsed AML. Patients may or may not have been exposed to any type of therapy before. * Any intensive chemotherapy regimen defined as a planned \ 4 week inpatient stay. Chemotherapy may be delivered for any number of days and on any schedule. Patients may be discharged from the hospital sooner than 4 weeks if the treating physician choose so, but the expectation at the initiation of chemotherapy must be \ 4 weeks of inpatient stay, as is typical. * Able to provide written voluntary consent before performance of any study related procedure.

Design outcomes

Primary

MeasureTime frameDescription
Abundance of PhylaDay 28Abundance in stool and circulating microbiota during intensive chemotherapy in patients with acute myeloid leukemia (AML), measured by16S rRNA gene profiling of biospecimens using the Illumina MiSeq platform
Abundance of GeneraDay 28Abundance in stool and circulating microbiota during intensive chemotherapy in patients with acute myeloid leukemia (AML), measured by16S rRNA gene profiling of biospecimens using the Illumina MiSeq platform

Secondary

MeasureTime frameDescription
Circulating Microbiota Diversity (Blood)Day 28Describe circulating microbiota diversity over the course of treatment
Microbiota Diversity (Stool)Day 28Describe stool microbiota diversity over the course of treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026