Analysis of the Gut Microbiota Composition After Consumption of Probiotic Bacteria

Not Applicable

Recruiting

• Conditions: Microbiota Analysis in Healthy Subjects

• Registration Number: NCT07046897
• Lead Sponsor: Lund University

Brief Summary

The goal of this intervention study is to evaluate the beneficial effect of the probiotic bacterium Bacillus coagulans in healthy volunteers. The main question it aims to answer is if the probiotic strains are modifying the microbiota composition in a beneficial way, evaluated in faecal- and saliva samples.

Primary hypothesis: The probiotic bacteria will modify the microbiota composition in faecal- and saliva samples.

Participants will consume the freeze-dried probiotic bacteria for 14 days. Before and after consumption, the participants will collect samples.

Detailed Description

Samples will be frozen immediately after collection and will be kept frozen until analysis at the Department of Process and Life Science Engineering, Faculty of Engineering, Lund University. For diversity measures, species identification and relative abundance of bacterial taxa, samples will be analysed by Illuminas MiSeq with the MiSeq reagent kit v3. Data will be analysed with bioinformatic pipeline QIIME2TM.

Study Timeline

• Study Start: 2024-11-12
• Study First Submitted: 2025-01-07
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• You must be 18-65 years of age.

Exclusion Criteria

• Participants must not be diagnosed with gastrointestinal diseases, autoimmune diseases or have diseases or medications that cause immune deficiency such as MS, type 1 diabetes, cancer or HIV.
• Participants must not have taken antibiotics in the month before or during the study.
• Participants must not consume other probiotic products or fermented foods during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The gut microbiota composition	At enrollment and after 2 weeks of consumption.	Diversity index will be calculated based on the results from next generation sequencing

Secondary Outcome Measures

Name	Time	Method
Relative abundance	At enrollment and after 2 weeks of consumption.	Quantification of bacterial taxa will be calculated based on the results from next generation sequencing

Trial Locations

Locations (1)

Department of Process and Life Science Engineering, Lund University; 🇸🇪 Lund, Sweden