Effect of Probiotic on the Gut Microbiota of Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy Adults

Intervention / Treatment
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* Dietary Supplement: a Bla80 group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Gut microbiota, Uric acid