Probiotics, Immune Function, and the Brain in Alcohol Consumers

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05232682

Enrollment

Registered

2022-02-10

Start date

2022-02-24

Completion date

2023-08-09

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol; Use, Problem

Keywords

alcohol use, probiotics, heavy drinking, brain, immune function

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTSeed DS-01 Daily Synbiotic

Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

Single group, open label trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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; * 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.

Design outcomes

Primary

Measure	Time frame	Description
Monocyte Chemoattractant Protein-1 (MCP-1)	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
Lipopolysaccharide Binding Protein (LBP)	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)	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)	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)	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
Tumor Necrosis Factor Alpha (TNF-a)	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

Countries

United States

Participant flow

Recruitment details

The study enrolled participants from February 2022 to November 2022. Participants were recruited from the Providence, Rhode Island, area using flyers and online advertising.

Pre-assignment details

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.

Participants by arm

Arm	Count
Probiotic Arm Probiotic arm Seed DS-01 Daily Synbiotic: Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)	16
Total	16

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	2

Baseline characteristics

Characteristic	Probiotic Arm
Age, Continuous	23.9 years STANDARD_DEVIATION 4.4
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Number of drinks in past 30 days	66.2 US standard drinks STANDARD_DEVIATION 33.5
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	6 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	6 Participants
Region of Enrollment United States	16 participants
Sex: Female, Male Female	4 Participants
Sex: Female, Male Male	12 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 16
other Total, other adverse events	0 / 16
serious Total, serious adverse events	0 / 16