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OpenTrials
Completed

NCT Number: NCT03316456

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

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.

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Key information

Conditions

Chemotherapy-Induced Gut Barrier Damage Acute Leukemia

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational: Stool Sample Collection

Diagnostic 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 Collection

Diagnostic 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 Collection

Diagnostic 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.

Primary outcomes

  1. Variation of Gut Microbiota Composition and Diversity

    Time frame: 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 outcomes

  1. Variation of Gut Barrier Integrity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
Oct 20, 2017
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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