Effect of Probiotic on the Gut Microbiota of Healthy Volunteers

Healthy Adults Clinical Trial

Official title:

Effect of Intervention With Probiotic on the Gut Microbiota of Healthy Volunteers: a Placebo-controlled Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06103253
• Other study ID #: WK2023005
• Status: Completed
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: June 28, 2023

Study information

• Verified date: October 2023
• Source: Wecare Probiotics Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 28, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Dietary Supplement:
• a Bla80 group
the BLa80 group received 2.9 g of maltodextrin + 0.1 g of BLa80 bacterial powder 10B daily.

Locations

Country	Name	City	State
China	National Engineering Laboratory for Deep Processing of wheat and corn	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Wecare Probiotics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gut microbiota diversity	Before and after taking probiotics, subjects' stool was collected, and stool 16s rRNA was detected by DNA extraction kit.	8 weeks