Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

— MicroAML  

Official title:

Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03881826
• Other study ID #: B403201317128
• Status: Completed
• Phase: N/A
• Start date: December 4, 2015
• Est. completion date: November 10, 2020

Study information

• Verified date: September 2021
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 10, 2020
• Est. primary completion date: January 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Cachexia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• collection of clinical data and biological samples
nutritional assessement cachexia symptoms urine, feces and blood samples

Locations

Country	Name	City	State
Belgium	UCLouvain	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Université Catholique de Louvain	European Society for Clinical Nutrition and Metabolism

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Changes in muscle strength	Measure of muscle strength with Jamar dynamometer (in kg)	at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Secondary	Changes in body composition	Measure of body composition by bio-electric impedance (in kg)	at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Secondary	Changes in appetite	Measure of appetite with the SNAQ questionnaire (score from 5 to 20)	at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Secondary	Changes in gut microbiota-related markers in the blood (gut permeability markers and microbial compounds)	ELISA (in pg/ml)	at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Secondary	Changes in gut microbiota-related markers in the blood (microbial metabolites)	1H-NMR metabolomics	at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Secondary	Changes in gut microbiota-related markers in urine (gut permeability markers, microbial compounds, microbial metabolites)	ELISA and 1H-NMR metabolomics	at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Secondary	Changes in gut microbiota composition in patients with acute myeloid leukemia before, during and after chemotherapy	Sequencing DNA extracts from patients' feces to obtain the description of gut microbiota composition in those patients.	at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Secondary	Changes in metabolites production by the gut microbiota in patients with acute myeloid leukemia before, during and after chemotherapy.	1H-NMR metabolomics performed on patients' feces to report the metabolites produced by the gut microbiota of those patients.	at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Secondary	Changes in number of participants with treatment related-related adverse events as assessed by CTCAE v4.0	CTCAE (common terminology criteria for adverse event version 4)	at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);

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