Clinical trial NCT03881826: Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia
Official title: Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Cachexia
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: European Society for Clinical Nutrition and Metabolism
First posted: 2019-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


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

Primary outcomes:
measure: Description of gut microbiota composition in patients with acute myeloid leukemia and control subjects
timeFrame: Day 0 i.e.: feces sampling is done at time of diagnosis before any chemotherapy
measure: Measure of metabolites production by the gut microbiota in patients with acute myeloid leukemia and control subjects
timeFrame: Day 0 i.e.: feces sampling is done at time of diagnosis before any chemotherapy
Secondary outcomes:
measure: Changes in muscle strength
timeFrame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
measure: Changes in body composition
timeFrame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
measure: Changes in appetite
timeFrame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
measure: Changes in gut microbiota-related markers in the blood (gut permeability markers and microbial compounds)
timeFrame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
measure: Changes in gut microbiota-related markers in the blood (microbial metabolites)
timeFrame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
measure: Changes in gut microbiota-related markers in urine (gut permeability markers, microbial compounds, microbial metabolites)
timeFrame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
measure: Changes in gut microbiota composition in patients with acute myeloid leukemia before, during and after chemotherapy
timeFrame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
measure: Changes in metabolites production by the gut microbiota in patients with acute myeloid leukemia before, during and after chemotherapy.
timeFrame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
measure: Changes in number of participants with treatment related-related adverse events as assessed by CTCAE v4.0
timeFrame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UCLouvain
Study officials:
References: