Effect of Probiotic on the Gut Microbiota of Healthy Volunteers

Not Applicable

Completed

• Conditions: Healthy Adults
• Interventions: Dietary Supplement: a Bla80 group

• Registration Number: NCT06103253
• Lead Sponsor: Wecare Probiotics Co., Ltd.

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.

Study Timeline

• Study Start: 2023-04-20
• Primary Completion: 2023-04-25
• Study Completion: 2023-06-28
• Status Verified: 2023-10
• Study First Submitted: 2023-10-21
• Study First Submitted QC: 2023-10-21
• Last Update Submitted: 2023-10-21
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• BMI ≥ 21

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	a Bla80 group	a placebo 27 group (maltodextrin)
Probiotic group	a Bla80 group	a Bla80 group (maltodextrin + strain BLa80 in 10B /day)

Primary Outcome Measures

Name	Time	Method
gut microbiota diversity	8 weeks	Before and after taking probiotics, subjects' stool was collected, and stool 16s rRNA was detected by DNA extraction kit.

Trial Locations

Locations (1)

National Engineering Laboratory for Deep Processing of wheat and corn; 🇨🇳 Zhengzhou, Henan, China