Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07371286

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Our study proposes testing a new therapeutic target for alcohol addiction: the gut microbiota, which could have a major impact on the prognosis for these patients, or for other addictive behaviors. Dietary fiber can modify alcohol-related intestinal dysbiosis and improve alcohol-induced changes in the intestinal barrier. Given the potential life-threatening nature of alcohol dependence, our study is the first to evaluate the effectiveness of a high-fiber diet in reducing alcohol consumption, increasing alcohol abstinence rates, and improving addictive behavior, cravings, and anxiety and depression symptoms in patients with severe alcohol addiction. The secondary objectives will allow us to study certain mechanisms involved in these effects, with a particular focus on the gut-brain axis. Given the difficulty of managing this chronic condition, if our results are positive, dietary fiber and dietary modulation could become an additional therapeutic option for alcohol withdrawal, improving prognosis and directly benefiting these patients. Furthermore, compared to other treatments used for alcohol addiction, fiber, through its mode of action, could also improve alcohol-related complications.

Although there is no official maximum intake for dietary fiber, excessive consumption, especially when the amount is increased dramatically over a short period of time, can cause minor, non-severe side effects such as gas and bloating. However, our intervention will not exceed the maximum recommended fiber intake recommended by scientific societies, which will reduce the risk of adverse effects. The constraints for patients are minimal and mainly involve eating the bite-sized pieces in addition to their usual meals and completing specific questionnaires to determine their impact on diet, addictive behaviors, and quality of life.

Subjects participating in the study will receive fiber-enriched food bite-sized pieces (16 bite-sized pieces/day for a total of 16 g of fiber: 8 g of inulin and 8 g of pectin) developed by Carembouche every day for 28 days. To increase compliance, different flavors will be offered (citrus, coffee, vanilla, chocolate) for the patient to choose from at the time of inclusion. The bite-sized pieces will be packaged in batches, one package per day, to be stored at room temperature. The bite-sized pieces will be supplied by Carembouche and stored in the department in a closed cupboard, away from light and in accordance with the manufacturer's instructions. Patients will receive the bite-sized pieces during their hospital stay and will return home with the quantity needed for the following 7 days. During the visit on day 14, patients will receive the quantity needed for the remaining 14 days of the protocol. The treatment includes a phase of gradual dose increase with 4 bite-sized pieces on day 1, 8 on day 2, 12 on day 3, and 16 from day 4 until the end of the study. During this adaptation period, patients will be able to choose flavors according to their taste preferences.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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 antibiotics, probiotics, or prebiotics in the 2 months prior to inclusion,
  • taking non-steroidal anti-inflammatory drugs or glucocorticoids in the month prior to inclusion.
  • taking baclofen, disulfiram, naltrexone, or acamprosate.
  • Participation in another interventional study involving human subjects or being in the exclusion period following a previous study involving human subjects, if applicable
  • Patients under AME
  • Patients under guardianship, trusteeship, or any other legal protection measure

Treatment and study plan

Administration of fibers as a dietary supplement

Dietary Supplement

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

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

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

    Time frame: From day 0 to day 28

  6. Markers of macrophage and neutrophil activation assessed by plasma assays of sCD163.

    Time frame: From day 0 to day 28

  7. Markers of macrophage and neutrophil activation assessed by plasma assays of sCD206.

    Time frame: From day 0 to day 28

  8. Markers of macrophage and neutrophil activation assessed by plasma assays of HMGB1.

    Time frame: From day 0 to day 28

  9. Markers of macrophage and neutrophil activation assessed by plasma assays of osteopontin.

    Time frame: From day 0 to day 28

  10. Evolution of the microbiome profile using 16s DNA sequencing

    Time frame: From day 0 to day 28

  11. Plasma levels of pro-inflammatory cytokines

    Time frame: From day 0 to day 28

    (CRP, ferritin, transferrin, TNF-α, IL-1β, IL-6, IL-8)

  12. Changes in biological and behavioural markers of alcohol consumption measured by plasma levels of carbohydrate-deficient transferrin (CDT)

    Time frame: From day 0 to day 28

  13. Changes in biological and behavioural markers of alcohol consumption measured by plasma levels of gamma glutamyltransferase (GGT).

    Time frame: From day 0 to day 28

  14. Changes in biological and behavioural markers of alcohol consumption measured by plasma levels of mean corpuscular volume (MCV).

    Time frame: From day 0 to day 28

  15. Changes in biological and behavioural markers of alcohol consumption measured by the abstinence rate assessed using the Alcohol Timeline Followback (TLFB) method.

    Time frame: From day 0 to day 28

  16. Changes in biological and behavioural markers of alcohol consumption measured by changes in craving intensity assessed by the OCDS (Obsessive-Compulsive Drinking Scale) craving score.

    Time frame: From day 0 to day 28

  17. Changes in biological and behavioural markers of alcohol consumption measured by changes in anxiety intensity as assessed by the Hamilton Anxiety Rating Scale (HARS).

    Time frame: From day 0 to day 28

  18. Changes in biological and behavioural markers of alcohol consumption measured by changes in impulsivity assessed using the Urgency Premeditation Perseverance Sensation (UPPS) impulsive behaviour scale.

    Time frame: From day 0 to day 28

  19. Changes in biological and behavioural markers of alcohol consumption measured by changes in the amount of alcohol consumed as assessed by the TLFB method.

    Time frame: From day 0 to day 28

  20. Changes in biological and behavioural markers of alcohol consumption measured by changes in biological markers of liver function (transaminases, alkaline phosphatase, bilirubin).

    Time frame: From day 0 to day 28

  21. Changes in biological and behavioural markers of alcohol consumption measured by progression of liver fibrosis and steatosis using non-invasive tests, assessed by liver elasticity.

    Time frame: From day 0 to day 28

  22. Changes in biological and behavioural markers of alcohol consumption measured by progression of liver fibrosis and steatosis using non-invasive tests, assessed by controlled attenuation parameter (CAP).

    Time frame: From day 0 to day 28

  23. Changes in biological and behavioural markers of alcohol consumption measured by progression of liver fibrosis and steatosis using non-invasive tests, assessed by biological fibrosis score.

    Time frame: From day 0 to day 28

  24. Changes in biological and behavioural markers of alcohol consumption measured by quality of life assessed by the 9-point Alcohol Dependence Quality of Life Scale (AlQoL9).

    Time frame: From day 0 to day 28

  25. Changes in biological and behavioural markers of alcohol consumption measured by changes in dietary behaviour assessed by the Food Frequency Questionnaire (FFQ).

    Time frame: From day 0 to day 28

  26. Changes in biological and behavioural markers of alcohol consumption measured by the collection of daily tolerance of adverse effects at each visit.

    Time frame: From day 0 to day 35

    Gastrointestinal symptoms will be measured using a French version of a self-reported questionnaire initially developed by gastroenterologists to assess symptoms of irritable bowel syndrome.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Marie CASSARD

CONTACT

[email protected]

+33 6 68 13 66 29

Dragos CIOCAN, MCU-PH

CONTACT

[email protected]

+33 1 45 37 43 69

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Administration of Fiber as a Dietary Supplement to Improve the Management of Alcohol Withdrawal - Randomized Controlled Open-label Study - FIB-ALC

Acronym: FIB-ALC

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.