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| ID | Type | Description | Link |
|---|---|---|---|
| P01AA019072 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Arm | Experimental | Probiotic arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seed DS-01 Daily Synbiotic | Dietary Supplement | Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement) |
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| Measure | Description | Time Frame |
|---|---|---|
| Lipopolysaccharide Binding Protein (LBP) | LBP levels in plasma | 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 | 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 | 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 | 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 | 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 | 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mollie Monnig, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02912 | United States |
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Of 32 participants enrolled for initial screening, 16 participants were fully eligible for the study after Visit 1 assessment and initiated the probiotic course. Two participants were lost to follow-up prior to completing the probiotic course. Fourteen participants completed the 30-day follow-up visit.
The study enrolled participants from February 2022 to November 2022. Participants were recruited from the Providence, Rhode Island, area using flyers and online advertising.
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| ID | Title | Description |
|---|---|---|
| FG000 | Probiotic Arm | Probiotic arm Seed DS-01 Daily Synbiotic: Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Probiotic Arm | Probiotic arm Seed DS-01 Daily Synbiotic: Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lipopolysaccharide Binding Protein (LBP) | LBP levels in plasma | Posted | Mean | Standard Deviation | ng/ml | 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group. |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Probiotic Arm | Probiotic arm Seed DS-01 Daily Synbiotic: Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mollie Monnig, PhD | Brown University | 4018633491 | mollie_monnig@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2022 | Apr 2, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 25, 2022 | Apr 2, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Single group, open label trial
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Participants were recruited from the greater Providence area in Rhode Island, USA. | Number | participants |
|
| Number of drinks in past 30 days | Mean | Standard Deviation | US standard drinks |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Primary | Soluble Cluster of Differentiation 14 (sCD14) | sCD14 levels in plasma | Posted | Mean | Standard Deviation | ng/ml | 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group. |
|
|
|
|
| Primary | Soluble Cluster of Differentiation 163 (sCD163) | sCD163 levels in plasma | Posted | Mean | Standard Deviation | ng/ml | 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group. |
|
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|
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| Primary | Interleukin-6 (IL-6) | IL-6 levels in plasma | Posted | Mean | Standard Deviation | pg/ml | 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group. |
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|
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| Primary | Monocyte Chemoattractant Protein-1 (MCP-1) | MCP-1 levels in plasma | Posted | Mean | Standard Deviation | pg/ml | 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group. |
|
|
|
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| Primary | Tumor Necrosis Factor Alpha (TNF-a) | TNF-a levels in plasma | Posted | Mean | Standard Deviation | pg/ml | 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group. |
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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| D004327 | Drinking Behavior |
| D001519 | Behavior |