Effect of Probiotic on the Gut Microbiota of Healthy Volunteers

NCT ID: NCT06103253

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2023-06-28

Brief Summary

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.

Detailed 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.

Conditions

Healthy Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo group

a placebo 27 group (maltodextrin)

Group Type: PLACEBO_COMPARATOR

a Bla80 group

Intervention Type: DIETARY_SUPPLEMENT

the BLa80 group received 2.9 g of maltodextrin + 0.1 g of BLa80 bacterial powder 10B daily.

Probiotic group

a Bla80 group (maltodextrin + strain BLa80 in 10B /day)

Group Type: ACTIVE_COMPARATOR

a Bla80 group

Intervention Type: DIETARY_SUPPLEMENT

the BLa80 group received 2.9 g of maltodextrin + 0.1 g of BLa80 bacterial powder 10B daily.

Interventions

a Bla80 group

the BLa80 group received 2.9 g of maltodextrin + 0.1 g of BLa80 bacterial powder 10B daily.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Engineering Laboratory for Deep Processing of wheat and corn

Zhengzhou, Henan, China

Countries

China

Other Identifiers

WK2023005

Identifier Type: -

Identifier Source: org_study_id