Analysis of the Gut Microbiota Composition After Consumption of Probiotic Bacteria
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Consumption of probiotics strain 5, Consumption of probiotics strain 6.
- Who it may be relevant to
- Registry conditions: Microbiota Analysis in Healthy Subjects. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement Consumption of probiotics strain 5
Consumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 5. - Dietary supplement Consumption of probiotics strain 6
Consumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 6.
Primary outcome measures
- The gut microbiota composition [Time frame: At enrollment and after 2 weeks of consumption.]
Secondary outcome measures (1)
- Relative abundance [Time frame: At enrollment and after 2 weeks of consumption.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Sweden · 1 center
- Department of Process and Life Science Engineering, Lund University — Lund
Identifiers
NCT: NCT07046897 · Lund University, LTH