Bacteria Capsules for Alcoholic Liver Disease
(IMPACT Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byJasmohan S Bajaj, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Virginia Commonwealth University
Must not be taking: Absorbable antibiotics
Disqualifiers: Illicit drugs, Mood disorders, Dialysis, others
Trial Summary
What is the purpose of this trial?The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, ongoing use of absorbable antibiotics is not allowed, so you may need to stop those if you are taking them.
What data supports the effectiveness of this treatment for alcoholic liver disease?
Research shows that fecal microbiota transplantation (FMT) is effective for treating Clostridium difficile infections and is being explored for other conditions like inflammatory bowel disease. Encapsulated FMT, similar to the bacteria capsules in this trial, has shown promise in these areas, suggesting potential benefits for alcoholic liver disease as well.
12345Is the use of bacteria capsules (FMT/IMT) generally safe for humans?
Fecal microbiota transplantation (FMT), which involves using bacteria capsules, is considered safe for treating recurrent Clostridium difficile infections and is being studied for other conditions. While more research is needed, studies have shown it to be a promising and generally safe approach for various conditions, including inflammatory bowel disease.
16789How is the treatment with Intestinal Microbiota Transplant (IMT) Capsules different from other treatments for alcoholic liver disease?
The Intestinal Microbiota Transplant (IMT) Capsules are unique because they aim to restore a healthy balance of gut bacteria, which is disrupted in alcoholic liver disease, by using bacteria from healthy donors. This approach is different from traditional treatments like steroids, which many patients cannot use or do not respond to, and it offers a potential new way to improve liver health and survival rates.
1011121314Eligibility Criteria
This trial is for adults over 18 with advanced liver disease due to alcohol use, who continue to drink despite previous attempts at treatment. They must be able to consent and not have withdrawal symptoms, significant drug use, uncontrolled mood disorders, certain allergies, a high MELD score (>17), or other severe health issues.Inclusion Criteria
Able to give written, informed consent
I am 18 years old or older.
My advanced liver disease is due to alcohol use.
+3 more
Exclusion Criteria
My liver disease diagnosis is unclear.
I am currently receiving dialysis.
Severe anaphylactic food allergy
+21 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either IMT capsules or placebo capsules, with capsules given twice on enrollment and after one month
3 months
8 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including tracking of hospitalizations and serious adverse events
4 months
Participant Groups
The study tests if capsules containing bacteria from healthy donors can reduce alcohol craving and consumption in patients with alcoholic liver disease. Participants will either receive the actual microbiota capsules or placebo capsules without active ingredients.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intestinal Microbiota Transplant capsulesExperimental Treatment1 Intervention
Capsules will be provided twice during the trial
Group II: Placebo capsulesPlacebo Group1 Intervention
Capsules will be provided twice during the trial
Intestinal Microbiota Transplant (IMT) Capsules is already approved in United States, European Union, United Kingdom for the following indications:
🇺🇸 Approved in United States as Fecal Microbiota Transplantation for:
- Recurrent Clostridioides difficile infection (CDI)
🇪🇺 Approved in European Union as Faecal Microbiota Transplantation for:
- Recurrent Clostridioides difficile infection (CDI)
- Severe to fulminant CDI
- Inflammatory bowel diseases including pouchitis
- Irritable bowel syndrome
🇬🇧 Approved in United Kingdom as Fecal Microbiota Transplantation for:
- Recurrent Clostridioides difficile infection (CDI)
- Refractory CDI
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hunter Holmes McGuire VA Medical CenterRichmond, VA
Virginia Commonwealth UniversityRichmond, VA
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Who Is Running the Clinical Trial?
Virginia Commonwealth UniversityLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study. [2022]Fecal microbiota transplantation (FMT) is a promising new strategy in the treatment of Inflammatory Bowel Disease, but long-term delivery systems are lacking. This randomized study was designed as a safety and feasibility study of long-term FMT in subjects with mild to moderate UC using frozen, encapsulated oral FMT (cFMT).
Systematic review with meta-analysis: review of donor features, procedures and outcomes in 168 clinical studies of faecal microbiota transplantation. [2020]Faecal microbiota transplantation (FMT) is effective for Clostridium difficile infections (CDI) refractory to standard treatment and is being studied in other diseases.
Faecal transplantation for IBD management-pitfalls and promises. [2022]Faecal microbiota transplantation (FMT) as a potential treatment for inflammatory bowel disease (IBD) is an area of active current research, having been stimulated by the remarkable efficacy of FMT in treatment of Clostridium difficile-associated colitis.
Systematic review with meta-analysis: encapsulated faecal microbiota transplantation - evidence for clinical efficacy. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">Faecal microbiota transplantation (FMT) is an effective treatment of recurrent Clostridioides difficile infection (rCDI) and is being applied experimentally in other diseases. Encapsulated administration may be equivalent in efficacy to delivery through other routes.
Therapeutic faecal microbiota transplantation: current status and future developments. [2021]Faecal microbiota transplantation (FMT) has undergone dramatic progression over the past year and continues to evolve as knowledge of the gastrointestinal microbiota (GiMb) develops. This review summarizes therapeutic advances in FMT, latest FMT therapies and presents the potential of FMT therapeutics in other gastrointestinal and extra-intestinal conditions.
The potential utility of fecal (or intestinal) microbiota transplantation in controlling infectious diseases. [2022]The intestinal microbiota is recognized to play a role in the defense against infection, but conversely also acts as a reservoir for potentially pathogenic organisms. Disruption to the microbiome can increase the risk of invasive infection from these organisms; therefore, strategies to restore the composition of the gut microbiota are a potential strategy of key interest to mitigate this risk. Fecal (or Intestinal) Microbiota Transplantation (FMT/IMT), is the administration of minimally manipulated screened healthy donor stool to an affected recipient, and remains the major 'whole microbiome' therapeutic approach at present. Driven by the marked success of using FMT in the treatment of recurrent Clostridioides difficile infection, the potential use of FMT in treating other infectious diseases is an area of active research. In this review, we discuss key examples of this treatment based on recent findings relating to the interplay between microbiota and infection, and potential further exploitations of FMT/IMT.
[Fecal microbiota transplantation : current status and prospects]. [2019]Fecal microbiota transplantation (FMT) is approved as a safe and effective treatment of recurrent Clostridium difficile infections. The technique is now being studied for other indications, usually involving chronic inflammation, metabolic disorders, or autoimmunity, for which the gut microbiota appears to play a key role. We detail thereafter, according to their degree of evidence, the potential future indications, in which FMT has already been tried on Humans. Except for ulcerative colitis and metabolic syndrome, the methodology of the published trials is often insufficiently described and inhomogeneous. Further randomized placebo-controlled trials and standardization of practice will be needed to confirm these preliminary but encouraging results.
Role of fecal microbiota transplantation in inflammatory bowel disease. [2018]There is increasing evidence of the key role played by altered intestinal microbiota in the pathogenesis of inflammatory bowel disease (IBD). Management strategies involving immune modulation are effective and widely used, but treatment failures and side effects occur. Fecal microbiota transplantation (FMT) provides a novel, perhaps complementary, strategy to restore the normal gut microbiota in patients with IBD. This review summarizes the available efficacy and safety data on the use of FMT in patients with IBD. Several aspects remain to be clarified about the clinical predictors of the response to FMT, its most appropriate route of administration, and the most appropriate quantity and quality of microbiota to be transplanted. Further studies focusing on long-term outcomes and safety are also warranted.
Regulatory Considerations for Fecal Microbiota Transplantation Products. [2020]Fecal microbiota for transplantation (FMT) is being studied as a potential intervention for numerous conditions. The regulation of FMT by the FDA is discussed along with FMT donor screening and manufacturing considerations. The FDA is committed to ensuring that FMT products can be safely tested in clinical trials.
Corticosteroids, nutrition, pentoxifylline, or fecal microbiota transplantation for severe alcoholic hepatitis. [2019]Alcohol-induced intestinal dysbiosis is central to the development of the severe alcoholic liver disease. We present the first study to compare outcomes in patients of severe alcoholic hepatitis (SAH) on nutritional therapy, corticosteroids, pentoxifylline, and healthy donor fecal transplantation (FMT) and discuss distinct microbial community and microbiome metabolic functional changes after FMT.
Healthy donor faecal transplant for corticosteroid non-responsive severe alcoholic hepatitis. [2019]Patients with severe alcoholic hepatitis (SAH) have high mortality in the presence of steroid unresponsiveness in the absence of clear treatment recommendations. Liver transplantation is the curative option in such cases but is controversial in the wake of severe infections, post-transplant recidivism and long waiting on deceased donor listing. Animal and human studies have shed light on the beneficial effects of gut microbiota modulation in alcoholic liver disease. We present the first report of faecal microbiota transplantation (FMT) in a steroid non-responder in whom, clinical, biochemical and liver disease severity scores improved post-FMT and demonstrate distinct bacterial population changes pre-FMT and post-FMT. Healthy donor FMT could be safe and efficacious in SAH not responding to corticosteroid treatment, as a bridge to liver transplantation (LT) or in candidates who are unwilling or not ideal for LT for improvement in short-term transplant free survival. Larger controlled studies are required for confirmation.
Fecal microbiota transplantation in alcohol related liver diseases. [2021]The current standard of care for severe alcoholic hepatitis (SAH) has several limitations in that only up to one-third of patients are eligible for steroid therapy. Additionally, steroids have their own issues: a portion of patients do not respond, while there is doubtful long-term benefit in those who do and a large proportion are ineligible to receive steroids entirely and hence have no definitive options for treatment. As such, there is a large gap between the problem and the available solutions. Alcohol causes dysbiosis and also disrupts gut barrier function, consequently promoting the translocation of microbial lipopolysaccharide into the portal circulation and liver. Therefore, probiotics, prebiotics, antibiotics, or transplantation of gut microbiota are likely to attenuate the dysbiosis-related liver insult. Fecal microbiota transplantation (FMT) is expected to have a role in managing alcoholic liver disease in general and SAH in particular by correcting dysbiosis, the primary insult. Results from mouse studies have suggested beyond doubt that alcohol-related liver injury is transferrable and also treatable by adopting FMT from suitable donors. Initial human trials from our center have affirmed benefits in human subjects with SAH as well, with both improvements in disease severity and as well as the rate of survival. Further studies addressing the head-to-head comparison of steroids and FMT are ongoing. Available preliminary data are promising and FMT and/or gut microbial modulation might become the standard of care in the near future for managing alcohol-related liver diseases, especially alcoholic hepatitis, with greater applicability, improved acceptability, and minimal side effects.
Long-term Outcomes of Stool Transplant in Alcohol-associated Hepatitis-Analysis of Clinical Outcomes, Relapse, Gut Microbiota and Comparisons with Standard Care. [2023]Healthy donor fecal microbiota transplantation (FMT) was preliminarily shown to have clinical benefits in hepatic encephalopathy (HE), severe alcohol-associated hepatitis (SAH), and alcohol use disorder. However, the long-term outcomes of FMT and the gut microbiota (GM) changes in patients with SAH are unknown.
Effect of Fecal Microbiota Transplantation on Non-Alcoholic Fatty Liver Disease: A Randomized Clinical Trial. [2022]The clinical efficacy of fecal microbiota transplantation (FMT) in patients with non-alcoholic fatty liver disease (NAFLD) and the variant effects of FMT on lean and obese NAFLD patients remain elusive. Our study aimed to determine the clinical efficacy and safety of FMT for patients with NAFLD, elucidating its different influences on lean and obese patients with NAFLD.