About this trial
The goal of this clinical trial is to demonstrate that a fiber-enriched diet (with a high proportion of inulin and pectin) combined with standard care can reduce intestinal permeability in patients with alcohol use disorder (AUD) aged between 19 and 65.
The hypothesis of our study is that a diet rich in different dietary fibers (mainly inulin and pectin), by modifying the gut microbiota and its metabolites, will induce a decrease in intestinal permeability, restore the composition of the gut microbiota and its metabolites, and further improve abstinence, levels of craving and anxiety, inflammation, steatosis, and hepatic fibrosis in patients with alcohol use disorder.
The study consists of two parallel groups (a group eating fiber-rich snacks every day for 28 days (in addition to their usual care) versus a group not eating any snacks).
Participants will be required to provide stool, blood, and saliva samples, and complete questionnaires.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women or men,
aged >18 and ≤ 65,
French-speaking,
active alcohol users (as defined by the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, DSM-5)
Disqualifiers
any other addictive disorder (except tobacco),
inflammatory bowel disease or any other chronic inflammatory disease,
current cancer,
metabolic diseases such as obesity (BMI ≥ 30 kg/m²) kg/m2) or a history of bariatric surgery,
Trial design
Parallel
Treatments tested in this trial
Administration of fibers as a dietary supplement
Dietary supplementFood bite-sized pieces containing 16 g of dietary fiber (pectin and inulin).
Treatment groups
Trial outcomes
Primary outcomes
50% reduction in plasma levels of circulating sCD14 (a surrogate marker of intestinal permeability and bacterial translocation), measured by enzyme-linked immunosorbent assay (ELISA).
Secondary outcomes
Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of lipopolysaccharide (LPS).
Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of lipopolysaccharide binding protein (LPB)
Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of flagellin.
Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of faecal albumin.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: