Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia

NCT03881826 | Completed

• 1 other identifier: B403201317128
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Myeloid Leukemia; Cachexia

Outcome Measures

Primary Outcomes (2)

• Description of gut microbiota composition in patients with acute myeloid leukemia and control subjects

  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

  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 Outcomes (9)

• Changes in muscle strength

  at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);

• Changes in body composition

  at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);

• Changes in appetite

  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)

  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)

  at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);

Study Arms (2)

Haematological patients

EXPERIMENTAL

Other: collection of clinical data and biological samples

Healthy volunteers

ACTIVE COMPARATOR

Other: collection of clinical data and biological samples

Interventions

collection of clinical data and biological samples OTHER

* nutritional assessement * cachexia symptoms * urine, feces and blood samples

Haematological patients; Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• Age \> 75 years
• Pregnancy
• BMI \>30
• Any history of chronic intestinal affections (Crohn disease, inflammatory bowel disease, gluten intolerance)
• Gastric bypass
• Current treatment with antidiabetic or hypoglycemic drugs

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• European Society for Clinical Nutrition and Metabolism: collaborator

Study Sites (1)

UCLouvain

Brussels, 1200, Belgium

Location

Related Publications (1)

• Potgens SA, Lecop S, Havelange V, Li F, Neyrinck AM, Neveux N, Maertens J, Walter J, Schoemans H, Delzenne NM, Bindels LB. Gut microbiota alterations induced by intensive chemotherapy in acute myeloid leukaemia patients are associated with gut barrier dysfunction and body weight loss. Clin Nutr. 2023 Nov;42(11):2214-2228. doi: 10.1016/j.clnu.2023.09.021. Epub 2023 Sep 25.

  PMID: 37806074 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Cachexia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: March 20, 2019
• Study Start: December 4, 2015
• Primary Completion: January 11, 2020
• Study Completion: November 10, 2020
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

BE (1)