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NCT Number: NCT03881826

Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia

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).

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Key information

Conditions

Acute Myeloid Leukemia Body Weight Body Weight Changes Cachexia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLouvain

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

collection of clinical data and biological samples

Other
  • nutritional assessement
  • cachexia symptoms
  • urine, feces and blood samples

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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)

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Collaborators

  • European Society for Clinical Nutrition and Metabolism

Registry information

Acronym: MicroAML

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 20, 2019
Registry last updated
Sep 22, 2021

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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