Effect of Probiotic on the Gut Microbiota of Healthy Volunteers

October 21, 2023 updated by: Wecare Probiotics Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450001
        • National Engineering Laboratory for Deep Processing of wheat and corn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
a placebo 27 group (maltodextrin)
Dietary supplement: a Bla80 group
the BLa80 group received 2.9 g of maltodextrin + 0.1 g of BLa80 bacterial powder 10B daily.
Active Comparator: Probiotic group
a Bla80 group (maltodextrin + strain BLa80 in 10B /day)
Dietary supplement: a Bla80 group
the BLa80 group received 2.9 g of maltodextrin + 0.1 g of BLa80 bacterial powder 10B daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gut microbiota diversity
Time Frame: 8 weeks
Before and after taking probiotics, subjects' stool was collected, and stool 16s rRNA was detected by DNA extraction kit.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wecare Probiotics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2023

Primary Completion (Actual)

April 25, 2023

Study Completion (Actual)

June 28, 2023

Study Registration Dates

First Submitted

October 21, 2023

First Submitted That Met QC Criteria

October 21, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 21, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WK2023005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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