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

Acute Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316456
• Other study ID #: 2017NTLS052
• Secondary ID: HM2017-21
• Status: Completed
• Start date: August 22, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: May 2019
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 1, 2019
• Est. primary completion date: December 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Chemotherapy-Induced Gut Barrier Damage
• Leukemia

Intervention

Diagnostic Test:
• Observational: Stool Sample Collection
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 Collection
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 Collection
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.

Locations

Country	Name	City	State
United States	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Three times weekly until day 28 of chemotherapy.
Secondary	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	Three times weekly until day 28 of chemotherapy