Acute Myeloid LeukemiaMicroAMLNCT03881826
Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia
A study testing collection of clinical data and biological samples in people with Acute Myeloid Leukemia and Cachexia, run by Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myeloid Leukemia, Cachexia
- What is being tested?
- collection of clinical data and biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Dec 2015to 10 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Any history of chronic intestinal affections (Crohn disease, inflammatory bowel disease, gluten intolerance)
- Gastric bypass
- Current treatment with antidiabetic or hypoglycemic drugs
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
•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
- Being tested
- collection of clinical data and biological samples
- Medical subject headings
- Leukemia, Myeloid, Acute, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of clinical data and biological samplesOther
- nutritional assessement
- cachexia symptoms
- urine, feces and blood samples
| Study group | Role | What they receive |
|---|---|---|
| Haematological patients | Experimental | Not described Receives: Other: collection of clinical data and biological samples |
| Healthy volunteers | Active comparator | Not described Receives: Other: collection of clinical data and biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 0 i.e.: feces sampling is done at time of diagnosis before any chemotherapy
Secondary outcomes (9)
Changes in muscle strength
Measure of muscle strength with Jamar dynamometer (in kg)
Measured: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Changes in body composition
Measure of body composition by bio-electric impedance (in kg)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start4 Dec 2015
- Primary completion11 Jan 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- European Society for Clinical Nutrition and Metabolism
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881826
- Sponsor's protocol ID
- B403201317128
- Acronym
- MicroAML
- Status last verified
- Sep 2021
- First submitted
- 5 Feb 2019
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37806074
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03881826
- Acronym / sponsor ID
- MicroAML / B403201317128
- Conditions
- Acute Myeloid Leukemia, Cachexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- European Society for Clinical Nutrition and Metabolism
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- 11 Jan 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haematological patients | Experimental | Other: collection of clinical data and biological samples |
| Healthy volunteers | Active comparator | Other: collection of clinical data and biological samples |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- Age < 18 years
- Age > 75 years
- Pregnancy
- Antibiotics consumption during the last 30 days before inclusion
- Recent chemotherapy (< 3 months), with exclusion of hydroxyurea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of clinical data and biological samples* nutritional assessement * cachexia symptoms * urine, feces and blood samples | Other | Haematological patients, Healthy volunteers |
Primary outcome
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
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
9 secondary outcomes
Changes in muscle strength
Time frame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Changes in body composition
Time frame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Changes in appetite
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Derived from this study: PubMed 37806074Potgens 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collection of clinical data and biological samples in people with Acute Myeloid Leukemia and Cachexia, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03881826, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.