NCT03881826: MicroAML

Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia

Completed NA Last updated 22 September 2021

What this trial tests

NA trial testing collection of clinical data and biological samples in Acute Myeloid Leukemia in 60 participants. Completed in 10 November 2020.

Timeline

4 December 2015

Primary endpoint
11 January 2020

10 November 2020

Quick facts

Lead sponsor	Université Catholique de Louvain
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	60
Start date	4 December 2015
Primary completion	11 January 2020
Estimated completion	10 November 2020
Sites	1 location across Belgium

Drugs / interventions tested

• collection of clinical data and biological samples

Conditions studied

• Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
• Cachexia — all drugs for Cachexia →

Sponsor

Université Catholique de Louvain — full company profile →

Who can join

Adults 18 to 75, any sex, with Acute Myeloid Leukemia or Cachexia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cachexia, a Systemic Disease beyond Muscle Atrophy.
   Wyart E, Bindels LB, Mina E, Menga A, et al · · 2020 · cited 36× · PMID 33202621 · DOI 10.3390/ijms21228592
2. Gut microbiota alterations induced by intensive chemotherapy in acute myeloid leukaemia patients are associated with gut barrier dysfunction and body weight loss.
   Pötgens SA, Lecop S, Havelange V, Li F, et al · · 2023 · cited 18× · PMID 37806074 · DOI 10.1016/j.clnu.2023.09.021
3. Gut microbiome alterations at acute myeloid leukemia diagnosis are associated with muscle weakness and anorexia.
   Pötgens SA, Havelange V, Lecop S, Li F, et al · · 2024 · cited 13× · PMID 38546675 · DOI 10.3324/haematol.2023.284138