Alcohol; Use, ProblemPhase 2NCT05232682
Probiotics, Immune Function, and the Brain in Alcohol Consumers
A Phase 2 study testing Seed DS-01 Daily Synbiotic in people with Alcohol; Use, Problem, run by Brown University at 1 site in United States.
Trial summary
This pilot project is a brief, open-label clinical trial of probiotics as an intervention in heavy drinkers. Heavy drinkers who do not yet show significant signs of liver disease may stand to benefit from probiotics, but no clinical trials to date have addressed this population. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol; Use, Problem
- What is being tested?
- Seed DS-01 Daily Synbiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2022to 9 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-64 years old;
- Able to speak and read English well enough to complete study procedures;
- Meets NIAAA guidelines for heavy drinking in the past 30 days.
Who cannot join
- Chronic disease requiring daily use of medication;
- Seeking or receiving treatment for alcohol/drug use, with exception of smoking cessation;
- Self-reported history of liver disease;
- Antibiotic or probiotic use in past 1 month;
- Positive urine drug test;
- History of fainting, weakness, infection, excessive bruising, or extreme distress from blood draw;
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- Safety contraindication for MRI (e.g., ferromagnetic implant in the body, claustrophobia);
- Head trauma with loss of consciousness >10 min;
- Pregnant, breastfeeding, or not using effective birth control;
- Unable to complete the study visits due to time or scheduling constraints;
- Weight <110 lbs.
- Conditions of immunodeficiency, such as HIV infection, primary immune deficiency, or taking immune-suppressant medications.
Trial locations and contacts
1 site in 1 country.
About this study
This pilot project is a brief, open-label clinical trial of probiotics as an intervention in heavy drinkers. Heavy drinkers who do not yet show significant signs of liver disease may stand to benefit from probiotics, but no clinical trials to date have addressed this population. This study will recruit heavy drinkers to complete an open-label within-subjects trial. The study will investigate effects of probiotics on specific biomarkers in healthy heavy drinkers who currently are not seeking to change their alcohol use (i.e., are non-treatment-seeking).
Read the detailed description
This pilot project is a brief, open-label clinical trial of probiotics as an intervention to reduce systemic and neural inflammation in heavy drinkers. Heavy drinkers who do not yet show significant signs of liver disease also may stand to benefit from probiotics, but no clinical trials to date have addressed this population. This study will recruit 15 non-treatment-seeking heavy drinkers to complete an open-label within-subjects trial. Aim 1 is to demonstrate proof-of-concept for beneficial effects of probiotic use on inflammatory processes. Aim 2 is to examine effects of probiotic use on brain metabolites correlated with neuroinflammation using magnetic resonance spectroscopy. Aim 3 is to gather preliminary data on acceptability and feasibility of the probiotic intervention in non-treatment-seeking heavy drinkers.
- Conditions
- Alcohol; Use, Problem
- Being tested
- Seed DS-01 Daily Synbiotic
- Keywords
- alcohol use, probiotics, heavy drinking, brain, immune function
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seed DS-01 Daily SynbioticDietary supplement
Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Arm | Experimental | Probiotic arm Receives: Dietary Supplement: Seed DS-01 Daily Synbiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipopolysaccharide Binding Protein (LBP)
LBP levels in plasma
Measured: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
Soluble Cluster of Differentiation 14 (sCD14)
sCD14 levels in plasma
Measured: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
Soluble Cluster of Differentiation 163 (sCD163)
sCD163 levels in plasma
Measured: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
Interleukin-6 (IL-6)
IL-6 levels in plasma
Measured: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
Monocyte Chemoattractant Protein-1 (MCP-1)
MCP-1 levels in plasma
Measured: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
Tumor Necrosis Factor Alpha (TNF-a)
TNF-a levels in plasma
Measured: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start24 Feb 2022
- Primary completion9 Aug 2023
- Study completion9 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol; Use, ProblemStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, open label trial
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Mollie Monnig, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232682
- Sponsor's protocol ID
- 2109003092
- Other IDs
- P01AA019072
- Status last verified
- Sep 2024
- First submitted
- 31 Jan 2022
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics, Immune Function, and the Brain in Alcohol Consumers
- ClinicalTrials.gov ID
- NCT05232682
- Acronym / sponsor ID
- 2109003092
- Conditions
- Alcohol; Use, Problem
- Keywords
- alcohol use, probiotics, heavy drinking, brain, immune function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot project is a brief, open-label clinical trial of probiotics as an intervention in heavy drinkers. Heavy drinkers who do not yet show significant signs of liver disease may stand to benefit from probiotics, but no clinical trials to date have addressed this population. This study will recruit heavy drinkers to complete an open-label within-subjects trial. The study will investigate effects of probiotics on specific biomarkers in healthy heavy drinkers who currently are not seeking to change their alcohol use (i.e., are non-treatment-seeking).
Detailed description
This pilot project is a brief, open-label clinical trial of probiotics as an intervention to reduce systemic and neural inflammation in heavy drinkers. Heavy drinkers who do not yet show significant signs of liver disease also may stand to benefit from probiotics, but no clinical trials to date have addressed this population. This study will recruit 15 non-treatment-seeking heavy drinkers to complete an open-label within-subjects trial. Aim 1 is to demonstrate proof-of-concept for beneficial effects of probiotic use on inflammatory processes. Aim 2 is to examine effects of probiotic use on brain metabolites correlated with neuroinflammation using magnetic resonance spectroscopy. Aim 3 is to gather preliminary data on acceptability and feasibility of the probiotic intervention in non-treatment-seeking heavy drinkers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, open label trial
| Arm | Type | Receives |
|---|---|---|
| Probiotic Arm | Experimental | Dietary Supplement: Seed DS-01 Daily SynbioticProbiotic arm |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-64 years old;
- Able to speak and read English well enough to complete study procedures;
- Meets NIAAA guidelines for heavy drinking in the past 30 days.
Key exclusion criteria (12 listed)
- Chronic disease requiring daily use of medication;
- Seeking or receiving treatment for alcohol/drug use, with exception of smoking cessation;
- Self-reported history of liver disease;
- Antibiotic or probiotic use in past 1 month;
- Positive urine drug test;
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 |
|---|---|---|
| Seed DS-01 Daily SynbioticDaily administration of Seed DS-01 Daily Synbiotic (dietary supplement) | Dietary supplement | Probiotic Arm |
Primary outcome
Lipopolysaccharide Binding Protein (LBP)
Time frame: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
LBP levels in plasma
Soluble Cluster of Differentiation 14 (sCD14)
Time frame: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
sCD14 levels in plasma
Soluble Cluster of Differentiation 163 (sCD163)
Time frame: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
sCD163 levels in plasma
Interleukin-6 (IL-6)
Time frame: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
IL-6 levels in plasma
Monocyte Chemoattractant Protein-1 (MCP-1)
Time frame: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
MCP-1 levels in plasma
Tumor Necrosis Factor Alpha (TNF-a)
Time frame: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
TNF-a levels in plasma
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mollie Monnig, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Seed DS-01 Daily Synbiotic in people with Alcohol; Use, Problem, run by Brown University at 1 site in United States.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipopolysaccharide Binding Protein (LBP) (time frame: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.). The study lists 6 primary outcomes in all. 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 19 Sep 2024.