Administration of fibers as a dietary supplement
Dietary SupplementFood bite-sized pieces containing 16 g of dietary fiber (pectin and inulin).
NCT Number: NCT07371286
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.
Trial opening soon.
Get Notified19 year–65 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Food bite-sized pieces containing 16 g of dietary fiber (pectin and inulin).
Time frame: From day 0 to day 28
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(CRP, ferritin, transferrin, TNF-α, IL-1β, IL-6, IL-8)
Time frame: From day 0 to day 28
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Time frame: From day 0 to day 28
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.
Contact information is provided by the study sponsor or research team.
Anne-Marie CASSARD
CONTACT
Dragos CIOCAN, MCU-PH
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Administration of Fiber as a Dietary Supplement to Improve the Management of Alcohol Withdrawal - Randomized Controlled Open-label Study - FIB-ALC
Acronym: FIB-ALC
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.
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