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

Université Catholique de Louvain

Status: Completed

Conditions: Cachexia; Acute Myeloid Leukemia

Treatments: Other: collection of clinical data and biological samples

Study type: Interventional

Funder types: Other

Identifiers

NCT03881826

B403201317128

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Haematological patients

Experimental group

Treatment:

Other: collection of clinical data and biological samples

Healthy volunteers

Active Comparator group

Treatment:

Other: collection of clinical data and biological samples