NCT06899620

Brief Summary

To assess the effectiveness and safety of probiotic strain BC179 in reducing alcohol absorption in the gut, thereby lowering health risks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

March 25, 2025

Last Update Submit

August 22, 2025

Conditions

Drinking Behavior

Outcome Measures

Primary Outcomes (1)

  • Effects of BC179 on alcohol metabolism

    The impact of BC179 on alcohol metabolism is assessed by monitoring blood alcohol concentration (BAC) and related enzyme activities, such as alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH).

    60 days

Study Arms (2)

Probiotic group

EXPERIMENTAL

10B CFU/Sachet/Day BC179 ; Storage: Store in cool and dry place without sun exposure

Dietary Supplement: Probiotic group

Placebo group

PLACEBO COMPARATOR

Dextrin one Sachet/Day; Storage: Store in cool and dry place without sun exposure

Dietary Supplement: Placebo group

Interventions

Probiotic groupDIETARY_SUPPLEMENT

The experimental phase of this study lasted for 60 days.

Probiotic group
Placebo groupDIETARY_SUPPLEMENT

The experimental phase of this study lasted for 60 days.

Placebo group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be aged between 18 and 65 years.
  • They should have a documented history of long-term alcohol consumption, defined as consuming at least 20 grams of ethanol per day for at least one year. This is calculated using the formula: volume (mL) × alcohol content (%) × 0.8.
  • They must provide written informed consent and be willing to comply with the study procedures.

You may not qualify if:

  • History of chronic liver, gastrointestinal, or systemic metabolic disorders.
  • Use of products with similar functions to the investigational formulation within the past two weeks.
  • Use of antibiotics, laxatives, or dietary supplements within the past four weeks.
  • Documented history of hypertension or diabetes.
  • Severe allergies or immune deficiencies.
  • Pregnancy, lactation, or planning pregnancy without effective contraception during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wu Ying

Luoyang, Henan, 471000, China

Location

MeSH Terms

Conditions

Drinking Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2025

First Posted

March 28, 2025

Study Start

July 1, 2024

Primary Completion

November 30, 2024

Study Completion

July 20, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)