Trial Outcomes & Findings for Probiotics, Immune Function, and the Brain in Alcohol Consumers (NCT NCT05232682)
NCT ID: NCT05232682
Last Updated: 2024-09-19
Results Overview
LBP levels in plasma
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
Results posted on
2024-09-19
Participant Flow
The study enrolled participants from February 2022 to November 2022. Participants were recruited from the Providence, Rhode Island, area using flyers and online advertising.
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.
Participant milestones
| Measure |
Probiotic Arm
Probiotic arm
Seed DS-01 Daily Synbiotic: Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Probiotic Arm
Probiotic arm
Seed DS-01 Daily Synbiotic: Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Probiotics, Immune Function, and the Brain in Alcohol Consumers
Baseline characteristics by cohort
| Measure |
Probiotic Arm
n=16 Participants
Probiotic arm
Seed DS-01 Daily Synbiotic: Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)
|
|---|---|
|
Age, Continuous
|
23.9 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
|
Number of drinks in past 30 days
|
66.2 US standard drinks
STANDARD_DEVIATION 33.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Probiotic Arm
n=16 Participants
Probiotic arm at baseline
Seed DS-01 Daily Synbiotic: Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)
|
Probiotic Arm at Follow-Up
n=14 Participants
Probiotic Arm within subjects at 30-day follow-up
|
|---|---|---|
|
Lipopolysaccharide Binding Protein (LBP)
|
23609.2 ng/ml
Standard Deviation 11451.8
|
28111.9 ng/ml
Standard Deviation 16621.6
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Probiotic Arm
n=16 Participants
Probiotic arm at baseline
Seed DS-01 Daily Synbiotic: Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)
|
Probiotic Arm at Follow-Up
n=14 Participants
Probiotic Arm within subjects at 30-day follow-up
|
|---|---|---|
|
Soluble Cluster of Differentiation 14 (sCD14)
|
3175.9 ng/ml
Standard Deviation 1577.3
|
3394.7 ng/ml
Standard Deviation 1973.2
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Probiotic Arm
n=16 Participants
Probiotic arm at baseline
Seed DS-01 Daily Synbiotic: Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)
|
Probiotic Arm at Follow-Up
n=14 Participants
Probiotic Arm within subjects at 30-day follow-up
|
|---|---|---|
|
Soluble Cluster of Differentiation 163 (sCD163)
|
518.6 ng/ml
Standard Deviation 288.1
|
560.9 ng/ml
Standard Deviation 205.2
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Probiotic Arm
n=16 Participants
Probiotic arm at baseline
Seed DS-01 Daily Synbiotic: Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)
|
Probiotic Arm at Follow-Up
n=14 Participants
Probiotic Arm within subjects at 30-day follow-up
|
|---|---|---|
|
Interleukin-6 (IL-6)
|
1.2 pg/ml
Standard Deviation 0.8
|
1.2 pg/ml
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Probiotic Arm
n=16 Participants
Probiotic arm at baseline
Seed DS-01 Daily Synbiotic: Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)
|
Probiotic Arm at Follow-Up
n=14 Participants
Probiotic Arm within subjects at 30-day follow-up
|
|---|---|---|
|
Monocyte Chemoattractant Protein-1 (MCP-1)
|
93.5 pg/ml
Standard Deviation 24.4
|
101.0 pg/ml
Standard Deviation 22.8
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Probiotic Arm
n=16 Participants
Probiotic arm at baseline
Seed DS-01 Daily Synbiotic: Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)
|
Probiotic Arm at Follow-Up
n=14 Participants
Probiotic Arm within subjects at 30-day follow-up
|
|---|---|---|
|
Tumor Necrosis Factor Alpha (TNF-a)
|
7.4 pg/ml
Standard Deviation 0.9
|
7.6 pg/ml
Standard Deviation 1.8
|
Adverse Events
Probiotic Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place