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Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia (MicroAML)

Primary Purpose

Acute Myeloid Leukemia, Cachexia

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
collection of clinical data and biological samples
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acute Myeloid Leukemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with

    • A diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML)
    • Acute leukemia's of ambiguous lineage according to WHO 2008
    • A diagnosis of refractory anemia with excess of blasts (MDS REAB) 2 and IPSS (International Prognostic Scoring System)-R score > 2.
  • World Health Organization performance status 0, 1 or 2
  • Sampled bone marrow and/ blood cells at diagnosis with molecular analysis.
  • Written informed consent
  • Good command of the French or Dutch language

Exclusion Criteria:

  • Age < 18 years
  • Age > 75 years
  • Pregnancy
  • Antibiotics consumption during the last 30 days before inclusion
  • Recent chemotherapy (< 3 months), with exclusion of hydroxyurea
  • BMI >30
  • Any history of chronic intestinal affections (Crohn disease, inflammatory bowel disease, gluten intolerance)
  • Gastric bypass
  • Current treatment with antidiabetic or hypoglycemic drugs

Sites / Locations

  • UCLouvain

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Haematological patients

Healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

Description of gut microbiota composition in patients with acute myeloid leukemia and control subjects
Sequencing DNA extracts from patients' feces (both patients with acute myeloid leukemia and control subjects matched for BMI, sex and age) to obtain the description of gut microbiota composition in those patients
Measure of metabolites production by the gut microbiota in patients with acute myeloid leukemia and control subjects
1H-NMR metabolomics performed on patients' feces (both patients with acute myeloid leukemia and control subjects matched for BMI, sex and age) to report the metabolites produced by the gut microbiota of those patients

Secondary Outcome Measures

Changes in muscle strength
Measure of muscle strength with Jamar dynamometer (in kg)
Changes in body composition
Measure of body composition by bio-electric impedance (in kg)
Changes in appetite
Measure of appetite with the SNAQ questionnaire (score from 5 to 20)
Changes in gut microbiota-related markers in the blood (gut permeability markers and microbial compounds)
ELISA (in pg/ml)
Changes in gut microbiota-related markers in the blood (microbial metabolites)
1H-NMR metabolomics
Changes in gut microbiota-related markers in urine (gut permeability markers, microbial compounds, microbial metabolites)
ELISA and 1H-NMR metabolomics
Changes in gut microbiota composition in patients with acute myeloid leukemia before, during and after chemotherapy
Sequencing DNA extracts from patients' feces to obtain the description of gut microbiota composition in those patients.
Changes in metabolites production by the gut microbiota in patients with acute myeloid leukemia before, during and after chemotherapy.
1H-NMR metabolomics performed on patients' feces to report the metabolites produced by the gut microbiota of those patients.
Changes in number of participants with treatment related-related adverse events as assessed by CTCAE v4.0
CTCAE (common terminology criteria for adverse event version 4)

Full Information

First Posted
February 5, 2019
Last Updated
September 21, 2021
Sponsor
Université Catholique de Louvain
Collaborators
European Society for Clinical Nutrition and Metabolism
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1. Study Identification

Unique Protocol Identification Number
NCT03881826
Brief Title
Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia
Acronym
MicroAML
Official Title
Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 4, 2015 (Actual)
Primary Completion Date
January 11, 2020 (Actual)
Study Completion Date
November 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain
Collaborators
European Society for Clinical Nutrition and Metabolism

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This cohort study aims to investigate the composition and activity of the gut microbiota of patients newly diagnosed for acute myeloid leukemia (AML), in relationship with their food habits and cachectic hallmarks. The recruitment for this study is currently ongoing with the help of clinicians, nurses and data managers at the Saint-Luc clinics, University Hospital Leuven (Campus Gasthuisberg) and University Hospital Gent. Primary Objective •To assess the composition and activity of the gut microbiota in patients with acute myeloid leukemia (AML) compared to matched control subjects. Secondary Objectives To investigate correlations between the gut microbiota, cachectic hallmarks and gut microbiota-related markers in the blood (gut permeability markers, microbial compounds, microbial metabolites). To characterize the changes in the gut microbial ecosystem that are induced by chemotherapy and associated with colitis. To assess whether the composition of the gut microbiota can predict the severity of chemotherapy-related colitis. Study Design This is an academic multi-centric prospective study. The study is composed of two cohorts (Fig. 1). In Cohort A, patients are included before any chemotherapy. Biological samples (urine, feces, blood) are collected, alongside information on nutritional habits, appetite and medical records. Muscle strength and body composition are also measured. Only patients receiving a standard chemotherapy are included in Cohort B. In Cohort B, biological samples are collected and body composition, muscle strength and appetite are evaluated at 2 different time points, at the end of the chemotherapy (T1) and at discharge (T4).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Cachexia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Haematological patients
Arm Type
Experimental
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
collection of clinical data and biological samples
Intervention Description
nutritional assessement cachexia symptoms urine, feces and blood samples
Primary Outcome Measure Information:
Title
Description of gut microbiota composition in patients with acute myeloid leukemia and control subjects
Description
Sequencing DNA extracts from patients' feces (both patients with acute myeloid leukemia and control subjects matched for BMI, sex and age) to obtain the description of gut microbiota composition in those patients
Time Frame
Day 0 i.e.: feces sampling is done at time of diagnosis before any chemotherapy
Title
Measure of metabolites production by the gut microbiota in patients with acute myeloid leukemia and control subjects
Description
1H-NMR metabolomics performed on patients' feces (both patients with acute myeloid leukemia and control subjects matched for BMI, sex and age) to report the metabolites produced by the gut microbiota of those patients
Time Frame
Day 0 i.e.: feces sampling is done at time of diagnosis before any chemotherapy
Secondary Outcome Measure Information:
Title
Changes in muscle strength
Description
Measure of muscle strength with Jamar dynamometer (in kg)
Time Frame
at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Title
Changes in body composition
Description
Measure of body composition by bio-electric impedance (in kg)
Time Frame
at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Title
Changes in appetite
Description
Measure of appetite with the SNAQ questionnaire (score from 5 to 20)
Time Frame
at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Title
Changes in gut microbiota-related markers in the blood (gut permeability markers and microbial compounds)
Description
ELISA (in pg/ml)
Time Frame
at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Title
Changes in gut microbiota-related markers in the blood (microbial metabolites)
Description
1H-NMR metabolomics
Time Frame
at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Title
Changes in gut microbiota-related markers in urine (gut permeability markers, microbial compounds, microbial metabolites)
Description
ELISA and 1H-NMR metabolomics
Time Frame
at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Title
Changes in gut microbiota composition in patients with acute myeloid leukemia before, during and after chemotherapy
Description
Sequencing DNA extracts from patients' feces to obtain the description of gut microbiota composition in those patients.
Time Frame
at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Title
Changes in metabolites production by the gut microbiota in patients with acute myeloid leukemia before, during and after chemotherapy.
Description
1H-NMR metabolomics performed on patients' feces to report the metabolites produced by the gut microbiota of those patients.
Time Frame
at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Title
Changes in number of participants with treatment related-related adverse events as assessed by CTCAE v4.0
Description
CTCAE (common terminology criteria for adverse event version 4)
Time Frame
at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with A diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML) Acute leukemia's of ambiguous lineage according to WHO 2008 A diagnosis of refractory anemia with excess of blasts (MDS REAB) 2 and IPSS (International Prognostic Scoring System)-R score > 2. World Health Organization performance status 0, 1 or 2 Sampled bone marrow and/ blood cells at diagnosis with molecular analysis. Written informed consent Good command of the French or Dutch language Exclusion Criteria: Age < 18 years Age > 75 years Pregnancy Antibiotics consumption during the last 30 days before inclusion Recent chemotherapy (< 3 months), with exclusion of hydroxyurea BMI >30 Any history of chronic intestinal affections (Crohn disease, inflammatory bowel disease, gluten intolerance) Gastric bypass Current treatment with antidiabetic or hypoglycemic drugs
Facility Information:
Facility Name
UCLouvain
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia

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