Analysis of the Gut Microbiota Composition After Consumption of Probiotic Bacteria
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Lund University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The gut microbiota composition
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Consumption of probiotics strain 5
The participants will consume a probiotic product, a capsule with freeze-dries bacteria (B. coagulans strain 5).
Intervention: Consumption of probiotics strain 5 (Dietary Supplement)
Consumption of probiotics strain 6
The participants will consume a probiotic product, a capsule with freeze-dries bacteria (B. coagulans strain 6).
Intervention: Consumption of probiotics strain 6 (Dietary Supplement)
Outcomes
Primary Outcomes
The gut microbiota composition
Time Frame: At enrollment and after 2 weeks of consumption.
Diversity index will be calculated based on the results from next generation sequencing
The gut microbiota composition
Time Frame: At enrollment and after 2 weeks of consumption.
Diversity index will be calculated based on the results from next generation sequencing
Secondary Outcomes
- Relative abundance(At enrollment and after 2 weeks of consumption.)