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

Masonic Cancer Center, University of Minnesota20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chemotherapy-Induced Gut Barrier Damage Acute Leukemia

Interventions

Observational: Stool Sample CollectionDIAGNOSTIC_TEST

Observational: 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.

Observational: Blood Sample CollectionDIAGNOSTIC_TEST

Observational: 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.

Observational: Urine Sample CollectionDIAGNOSTIC_TEST

Observational: 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults (ages 18 - 99 years) undergoing inpatient induction chemotherapy for newly diagnosed or relapsed acute leukemia (myeloid or lymphoblastic). * Any induction regimen (standard or experimental) with planned \~4 weeks of inpatient stay * Able to provide written voluntary consent before performance of any study related procedure.

Outcomes

Primary Outcomes

Variation of Gut Microbiota Composition and Diversity

Variation of gut microbiota composition and diversity, as determined by 16s rRNA sequencing of serial stool samples, during induction chemotherapy in acute leukemia patients.

Time frame: Three times weekly until day 28 of chemotherapy.

Secondary Outcomes

Variation of Gut Barrier Integrity

Variation of gut barrier integrity, as determined by serum levels of zonulin, I-FABP, and citrulline, during induction chemotherapy in acute leukemia patients

Time frame: Three times weekly until day 28 of chemotherapy