Administration of Fiber as a Dietary Supplement to Improve the Management of Alcohol Withdrawal

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-65
SponsorAssistance Publique - Hôpitaux de Paris

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Administration of fibers as a dietary supplement

    Dietary supplement

    Food bite-sized pieces containing 16 g of dietary fiber (pectin and inulin).

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Experimental arm taking food bite-sized pieces containing 16 g of dietary fiber (pectin and inulin)Experimental treatment 1 intervention
Group B: Control arm that will not consume the bite-sized piecesNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

50% reduction in plasma levels of circulating sCD14 (a surrogate marker of intestinal permeability and bacterial translocation), measured by enzyme-linked immunosorbent assay (ELISA).

Time frame
From day 0 to day 28

Secondary outcomes

1

Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of lipopolysaccharide (LPS).

Time frame
From day 0 to day 28
2

Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of lipopolysaccharide binding protein (LPB)

Time frame
From day 0 to day 28
3

Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of flagellin.

Time frame
From day 0 to day 28
4

Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of faecal albumin.

Time frame
From day 0 to day 28

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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