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| Name | Class |
|---|---|
| European Society for Clinical Nutrition and Metabolism | OTHER |
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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haematological patients | Experimental |
| |
| Healthy volunteers | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collection of clinical data and biological samples | Other |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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); |
| Changes in body composition |
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Inclusion Criteria:
Patients with
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLouvain | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37806074 | Derived | 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. |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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); |
| 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); |
| 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); |
| 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); |
| 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); |
| 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); |
| 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); |
| 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); |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |