Clinical trials are essential to evaluate the translational potential of our findings issued from preclinical models. For this reason, several clinical trials have been launched by the MNUT team in close collaboration with clinicians, whose names and affiliations are details on the related websites. Three of them are described below: the MicroAML, the FOOD4GUT, the FIBERTAG, the Gut2Brain_ClinX and the Microbes4Uc studies. MNUT PI are also involved as collaborators for other international studies.
To evaluate the translational value of the experimental work linking the gut microbiota to cancer cachexia, we have recently launched the MicroAML study. The MicroAML study aims to evaluate the composition and activity of the gut microbiota in patients with acute myeloid leukemia. Information related to appetite, food habits, body composition and muscle strength as well as biological samples are collected before any chemotherapy (additional details available online at https://uclouvain.be/fr/node/43424 ). First results are expected for 2020.
FOOD4GUT is a multidisciplinary and inter-university project that aims to demonstrate that changing the microbiota via supplementation with inulin-type fructans accompanied by dietary advice promoting the consumption of vegetables rich in these colonic nutrients, may modulate obesity. We have recently shown that dietary intervention with vegetables naturally rich in fructans for two weeks can selectively modulate the gut microbiota and improved appetite and food intake behaviour (Hiel, Bindels et al Am J Clin Nutr 2019). A simple-blind placebo-controlled randomized multi-center trial has been conducted to highlight the interest for the health of vegetables in inulin-type fructans in obese adults. More information is available on the website of the FOOD4GUT project (Food4Gut project, lead by N. Delzenne, clinical coordination UCLouvain J.P. Thissen - https://sites.uclouvain.be/FOOD4GUT).
Our data obtained in alcohol dependent patients allowed to point out that the gut microbiota characteristics (and related gut barrier) are factors driving the depression and related behaviour in alcohol-dependent patients (Leclercq et al PNAS 2014). An intervention study (Gut2Brain_ClinX study) with inulin-type fructans has been initiated in 2018 in a cohort of alcohol-dependent patients of St Luc Hospital (under the supervision of Ph de Timary and P. Starkel), in order to try modulating the gut microbiota to counteract gut dysbiosis and related social and mental disorders. The intervention study has been completed in December 2019.
The FiberTAG project aims at establishing a set of biomarkers linking dietary fiber (DF) intake and gut-microbiota related health effect, by using existing cohorts of healthy or overweight populations, as well as in intervention studies with dietary fibers (chitin glutan), programmed in healthy volunteers and in patients at risk for cardiometabolic health. More information on the website: https://www.fibertag.eu/
The Microbes4U study investigates the effects of an oral administration of Akkermansia muciniphila on metabolic disorders associated with overweight and obesity. After the inclusion according to specific criteria, the volunteers were randomly assigned into 4 different groups: one placebo group, two others groups receiving live Akkermansia muciniphila 109 cells/day or 1010 cells/day and the last group receiving pasteurized Akkermansia muciniphila. The supplementation lasts for 3 months. Different parameters were recorded such as anthropometric parameters, lipid and glucose metabolic markers, and inflammation, the study is now published in Depommier et al. Nature Medicine 2019.