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

September 21, 2021 updated by: Université Catholique de Louvain

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • UCLouvain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy volunteers
Other: collection of clinical data and biological samples
  • nutritional assessement
  • cachexia symptoms
  • urine, feces and blood samples
Experimental: Haematological patients
Other: collection of clinical data and biological samples
  • nutritional assessement
  • cachexia symptoms
  • urine, feces and blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of gut microbiota composition in patients with acute myeloid leukemia and control subjects
Time Frame: Day 0 i.e.: feces sampling is done at time of diagnosis before any chemotherapy
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
Day 0 i.e.: feces sampling is done at time of diagnosis before any chemotherapy
Measure of metabolites production by the gut microbiota in patients with acute myeloid leukemia and control subjects
Time Frame: Day 0 i.e.: feces sampling is done at time of diagnosis before any chemotherapy
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
Day 0 i.e.: feces sampling is done at time of diagnosis before any chemotherapy

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Catholique de Louvain

Collaborators

European Society for Clinical Nutrition and Metabolism

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2015

Primary Completion (Actual)

January 11, 2020

Study Completion (Actual)

November 10, 2020

Study Registration Dates

First Submitted

February 5, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (Actual)

March 20, 2019

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B403201317128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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