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

Completed

• Conditions: Chemotherapy-Induced Gut Barrier Damage; Acute Leukemia

• Registration Number: NCT03316456
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-22
• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-20
• Primary Completion: 2017-12-26
• Study Completion: 2019-04-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variation of Gut Microbiota Composition and Diversity	Three times weekly until day 28 of chemotherapy.	Variation of gut microbiota composition and diversity, as determined by 16s rRNA sequencing of serial stool samples, during induction chemotherapy in acute leukemia patients.

Secondary Outcome Measures

Name	Time	Method
Variation of Gut Barrier Integrity	Three times weekly until day 28 of chemotherapy	Variation of gut barrier integrity, as determined by serum levels of zonulin, I-FABP, and citrulline, during induction chemotherapy in acute leukemia patients

Trial Locations

Locations (1)

Masonic Cancer Center at University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States