Alcohol Use DisorderFIB-ALCNCT07371286
Administration of Fiber as a Dietary Supplement to Improve the Management of Alcohol Withdrawal
A study testing Administration of fibers as a dietary supplement in people with Alcohol Use Disorder and Supplementation, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Supplementation, Intestinal Permeability
- What is being tested?
- Administration of fibers as a dietary supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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,
Show all 14Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Administration of Fiber as a Dietary Supplement to Improve the Management of Alcohol Withdrawal - Randomized Controlled Open-label Study - FIB-ALC
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Administration of fibers as a dietary supplement
- Keywords
- Alcohol, Dietary fibers, Food supplementation, Intestinal permeability, Misuse
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of fibers as a dietary supplementDietary supplement
Food bite-sized pieces containing 16 g of dietary fiber (pectin and inulin).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
50% reduction in plasma levels of circulating sCD14 (a surrogate marker of intestinal permeability and bacterial translocation), measured by enzyme-linked immunosorbent assay (ELISA).
Measured: 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).
Measured: From day 0 to day 28
Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of lipopolysaccharide binding protein (LPB)
Measured: From day 0 to day 28
Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of flagellin.
Measured: From day 0 to day 28
Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of faecal albumin.
Measured: From day 0 to day 28
Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of zonulin.
Measured: From day 0 to day 28
Markers of macrophage and neutrophil activation assessed by plasma assays of sCD163.
Measured: From day 0 to day 28
Markers of macrophage and neutrophil activation assessed by plasma assays of sCD206.
Measured: From day 0 to day 28
Markers of macrophage and neutrophil activation assessed by plasma assays of HMGB1.
Measured: From day 0 to day 28
Markers of macrophage and neutrophil activation assessed by plasma assays of osteopontin.
Measured: From day 0 to day 28
Evolution of the microbiome profile using 16s DNA sequencing
Measured: From day 0 to day 28
Plasma levels of pro-inflammatory cytokines
(CRP, ferritin, transferrin, TNF-α, IL-1β, IL-6, IL-8)
Measured: From day 0 to day 28
Changes in biological and behavioural markers of alcohol consumption measured by plasma levels of carbohydrate-deficient transferrin (CDT)
Measured: From day 0 to day 28
Changes in biological and behavioural markers of alcohol consumption measured by plasma levels of gamma glutamyltransferase (GGT).
Measured: From day 0 to day 28
Changes in biological and behavioural markers of alcohol consumption measured by plasma levels of mean corpuscular volume (MCV).
Measured: From day 0 to day 28
Changes in biological and behavioural markers of alcohol consumption measured by the abstinence rate assessed using the Alcohol Timeline Followback (TLFB) method.
Measured: From day 0 to day 28
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.
Measured: From day 0 to day 28
Changes in biological and behavioural markers of alcohol consumption measured by changes in anxiety intensity as assessed by the Hamilton Anxiety Rating Scale (HARS).
Measured: From day 0 to day 28
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.
Measured: From day 0 to day 28
Changes in biological and behavioural markers of alcohol consumption measured by changes in the amount of alcohol consumed as assessed by the TLFB method.
Measured: From day 0 to day 28
Changes in biological and behavioural markers of alcohol consumption measured by changes in biological markers of liver function (transaminases, alkaline phosphatase, bilirubin).
Measured: From day 0 to day 28
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.
Measured: From day 0 to day 28
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).
Measured: From day 0 to day 28
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.
Measured: From day 0 to day 28
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).
Measured: From day 0 to day 28
Changes in biological and behavioural markers of alcohol consumption measured by changes in dietary behaviour assessed by the Food Frequency Questionnaire (FFQ).
Measured: From day 0 to day 28
Changes in biological and behavioural markers of alcohol consumption measured by the collection of daily tolerance of adverse effects at each visit.
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.
Measured: From day 0 to day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carine PARE, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371286
- Sponsor's protocol ID
- 2025-A00575-44/1
- Acronym
- FIB-ALC
- Status last verified
- Oct 2025
- First submitted
- 24 Nov 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Fiber as a Dietary Supplement to Improve the Management of Alcohol Withdrawal - Randomized Controlled Open-label Study - FIB-ALC
- ClinicalTrials.gov ID
- NCT07371286
- Acronym / sponsor ID
- FIB-ALC / 2025-A00575-44/1
- Keywords
- Alcohol, Dietary fibers, Food supplementation, Intestinal permeability, Misuse
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm taking food bite-sized pieces containing 16 g of dietary fiber (pectin and inulin) | Experimental | Dietary Supplement: Administration of fibers as a dietary supplementgroup receiving 16 fiber-enriched bite-sized pieces (16 g of fiber in total: 8 g of pectin and 8 g of inulin) |
| 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 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of fibers as a dietary supplementFood bite-sized pieces containing 16 g of dietary fiber (pectin and inulin). | Dietary supplement | Experimental arm taking food bite-sized pieces containing 16 g of dietary fiber (pectin and inulin) |
Primary outcome
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
26 secondary outcomes
Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of lipopolysaccharide (LPS).
Time frame: From day 0 to day 28
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
Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of flagellin.
Time frame: From day 0 to day 28
Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of faecal albumin.
Time frame: From day 0 to day 28
Markers of intestinal integrity (intestinal permeability and bacterial translocation) assessed by plasma measurements of zonulin.
Time frame: From day 0 to day 28
Markers of macrophage and neutrophil activation assessed by plasma assays of sCD163.
Time frame: From day 0 to day 28
Markers of macrophage and neutrophil activation assessed by plasma assays of sCD206.
Time frame: From day 0 to day 28
Markers of macrophage and neutrophil activation assessed by plasma assays of HMGB1.
Time frame: From day 0 to day 28
Markers of macrophage and neutrophil activation assessed by plasma assays of osteopontin.
Time frame: From day 0 to day 28
Evolution of the microbiome profile using 16s DNA sequencing
Time frame: From day 0 to day 28
Plasma levels of pro-inflammatory cytokines
Time frame: From day 0 to day 28
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carine PARE study director
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing Administration of fibers as a dietary supplement in people with Alcohol Use Disorder and Supplementation, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dragos CIOCAN, MCU-PH (+33 1 45 37 43 69, dragosmarius.ciocan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.