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

NCT07371286 | Not Yet Recruiting

• 1 other identifier: 2025-A00575-44/1
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alcohol Use Disorder; Supplementation; Intestinal Permeability

Keywords

Alcohol; Dietary fibers; Food supplementation; Intestinal permeability; Misuse

Outcome Measures

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).

  From day 0 to day 28

Secondary Outcomes (26)

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

  From day 0 to day 28

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

  From day 0 to day 28

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

  From day 0 to day 28

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

  From day 0 to day 28

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

  From day 0 to day 28

Study Arms (2)

Experimental arm taking food bite-sized pieces containing 16 g of dietary fiber (pectin and inulin)

EXPERIMENTAL

group receiving 16 fiber-enriched bite-sized pieces (16 g of fiber in total: 8 g of pectin and 8 g of inulin)

Dietary Supplement: Administration of fibers as a dietary supplement

Control arm that will not consume the bite-sized pieces

NO INTERVENTION

Patients in this arm will not consume the bite-sized pieces and will follow the usual care protocol

Interventions

Administration of fibers as a dietary supplement DIETARY_SUPPLEMENT

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

Experimental arm taking food bite-sized pieces containing 16 g of dietary fiber (pectin and inulin)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• who agree to be hospitalized for alcohol withdrawal for a period of 7 days
• Affiliated with or eligible for social security.
• Negative pregnancy test (for patients of childbearing age)

You may not qualify if:

• 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,
• severe cognitive impairment (MMSE \< 24),
• psychiatric comorbidities including suicide risk,
• cirrhosis or significant fibrosis (≥F2) defined by a Fibroscan value \>7.6 kPa,
• pregnancy or breastfeeding,
• taking baclofen, disulfiram, naltrexone, or acamprosate.
• Patients under AME
• Patients under guardianship, trusteeship, or any other legal protection measure

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Carine PARE

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Dragos CIOCAN, MCU-PH

CONTACT

+33 1 45 37 43 69; dragosmarius.ciocan@aphp.fr

Anne-Marie CASSARD

CONTACT

+33 6 68 13 66 29; cassard.doulcier@universite-paris-saclay.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 27, 2026
• Study Start: February 1, 2026
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2025-10