ClinicalTrials.Veeva

Menu

Effect of Probiotic on the Gut Microbiota of Healthy Volunteers

W

Wecare Probiotics

Status

Completed

Conditions

Healthy Adults

Treatments

Dietary Supplement: a Bla80 group

Study type

Interventional

Funder types

Industry

Identifiers

NCT06103253
WK2023005

Details and patient eligibility

About

The goal of this placebo-controlled randomized trial is to test the effect of intervention with Bifidobacterium animalis subsp. lactis BLa80 on the composition of the gut microbiota of healthy volunteers. The main question it aims to answer is whether probiotic can effectively regulate intestinal flora. Participants will take a package of probiotics every day, and their weight was recorded once a week using a weight scale. Blood and stool tests were conducted before and after taking probiotics.

Full description

This placebo-controlled study aims to investigate the effect of Bifidobacterium animalis subsp. lactis BLa80 supplementation on the status of the gut microbiota of healthy participants. 112 subjects were randomly divided into a placebo group (maltodextrin) and a Bla80 group (maltodextrin + strain BLa80 in 1 × 10 10 colony-forming units/day). The intervention lasted 8 weeks, and 16S rRNA sequencing technology was used to study the changes in gut microbiota between different groups. Simultaneously, clinical indicators such as alanine transaminase (ALT), aspartate aminotransferase (AST), and uric acid (UC) were measured to illustrate the metabolic effects of BLa80.

Enrollment

112 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • BMI ≥ 21

Exclusion criteria

  • Those who have been diagnosed with diabetes or have high blood sugar are not recommended to participate in the test;
  • People whose daily diet is too light or too greasy are not recommended to participate in the test; People with special dietary structure caused by weight loss or other reasons (such as ketogenic diet, etc.) are not recommended to participate in the test;
  • Other people with special circumstances are not recommended to participate, such as those who are allergic to probiotic products; Pregnant women, breastfeeding women and people under 19 years old and over 45 years old should not be tested.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

112 participants in 2 patient groups, including a placebo group

Placebo group
Placebo Comparator group
Description:
a placebo 27 group (maltodextrin)
Treatment:
Dietary Supplement: a Bla80 group
Probiotic group
Active Comparator group
Description:
a Bla80 group (maltodextrin + strain BLa80 in 10B /day)
Treatment:
Dietary Supplement: a Bla80 group

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems