Analysis of the Gut Microbiota Composition After Consumption of Probiotic Bacteria
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLund University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Consumption of probiotics strain 5
Dietary supplementConsumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 5.
Consumption of probiotics strain 6
Dietary supplementConsumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 6.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Consumption of probiotics strain 5Experimental treatment 1 intervention
Group B: Consumption of probiotics strain 6Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The gut microbiota composition
Diversity index will be calculated based on the results from next generation sequencing
Time frame
At enrollment and after 2 weeks of consumption.Secondary outcomes
1
Relative abundance
Quantification of bacterial taxa will be calculated based on the results from next generation sequencing
Time frame
At enrollment and after 2 weeks of consumption.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov