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CompletedNCT03316456

Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction

The Role of Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction Chemotherapy

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
Masonic Cancer Center, University of Minnesota · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

Summary

This is an observational study to collect stool, blood, and urine from acute leukemia patients undergoing induction chemotherapy in order to generate preliminary data regarding the association between microbiota and chemotherapy-induced gut barrier damage. This study consists of inpatient collections of blood, urine, and stool while the patients are undergoing inpatient induction therapy. Patients will not be scheduled for any additional procedures or testing beyond what is required for clinical care.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTObservational: Stool Sample CollectionObservational: Stool Sample Collection \- Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner.
DIAGNOSTIC_TESTObservational: Blood Sample CollectionObservational: Blood Sample Collection \- Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner.
DIAGNOSTIC_TESTObservational: Urine Sample CollectionObservational: Urine Sample Collection \- Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner.

Timeline

Start date
2017-08-22
Primary completion
2017-12-26
Completion
2019-04-01
First posted
2017-10-20
Last updated
2019-05-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03316456. Inclusion in this directory is not an endorsement.

Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction (NCT03316456) · Clinical Trials Directory