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Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia (MicroAML)

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ClinicalTrials.gov Identifier: NCT03881826
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
European Society for Clinical Nutrition and Metabolism (ESPEN)
Information provided by (Responsible Party):
Université Catholique de Louvain

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).


Condition or disease Intervention/treatment
Acute Myeloid Leukemia Cachexia Other: collection of clinical data and biological samples

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia
Actual Study Start Date : December 4, 2015
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : December 31, 2022


Group/Cohort Intervention/treatment
Haematological patients Other: collection of clinical data and biological samples
  • nutritional assessement
  • cachexia symptoms
  • urine, feces and blood samples

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




Primary Outcome Measures :
  1. Description of gut microbiota composition in patients with acute myeloid leukemia and control subjects [ Time Frame: Day 0 i.e.: feces sampling is done at time of diagnosis before any chemotherapy ]
    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

  2. Measure of metabolites production by the gut microbiota in patients with acute myeloid leukemia and control subjects [ Time Frame: Day 0 i.e.: feces sampling is done at time of diagnosis before any chemotherapy ]
    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


Secondary Outcome Measures :
  1. Changes in muscle strength [ Time Frame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy); ]
    Measure of muscle strength with Jamar dynamometer (in kg)

  2. Changes in body composition [ Time Frame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy); ]
    Measure of body composition by bio-electric impedance (in kg)

  3. Changes in appetite [ Time Frame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy); ]
    Measure of appetite with the SNAQ questionnaire (score from 5 to 20)

  4. Changes in gut microbiota-related markers in the blood (gut permeability markers and microbial compounds) [ Time Frame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy); ]
    ELISA (in pg/ml)

  5. Changes in gut microbiota-related markers in the blood (microbial metabolites) [ Time Frame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy); ]
    1H-NMR metabolomics

  6. Changes in gut microbiota-related markers in urine (gut permeability markers, microbial compounds, microbial metabolites) [ Time Frame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy); ]
    ELISA and 1H-NMR metabolomics

  7. Changes in gut microbiota composition in patients with acute myeloid leukemia before, during and after chemotherapy [ Time Frame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy); ]
    Sequencing DNA extracts from patients' feces to obtain the description of gut microbiota composition in those patients.

  8. Changes in metabolites production by the gut microbiota in patients with acute myeloid leukemia before, during and after chemotherapy. [ Time Frame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy); ]
    1H-NMR metabolomics performed on patients' feces to report the metabolites produced by the gut microbiota of those patients.

  9. Changes in number of participants with treatment related-related adverse events as assessed by CTCAE v4.0 [ Time Frame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy); ]
    CTCAE (common terminology criteria for adverse event version 4)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881826


Contacts
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Contact: Laure Bindels, PhD laure.bindels@uclouvain.be

Locations
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Belgium
UCLouvain Recruiting
Brussels, Belgium, 1200
Contact: Laure Bindels, PhD         
Sponsors and Collaborators
Université Catholique de Louvain
European Society for Clinical Nutrition and Metabolism (ESPEN)
Additional Information:
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Responsible Party: Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03881826    
Other Study ID Numbers: B403201317128
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cachexia
Neoplasms by Histologic Type
Neoplasms
Emaciation
Weight Loss
Body Weight Changes
Body Weight