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Completed

NCT Number: NCT06103253

Effect of Probiotic on the Gut Microbiota of Healthy Volunteers

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Engineering Laboratory for Deep Processing of wheat and corn

Zhengzhou, Henan, 450001, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

a Bla80 group

Dietary Supplement

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2023
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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