Department of Process and Life Science Engineering, Lund University
Lund, 22100, Sweden
Location status: Recruiting
Recruiting
NCT Number: NCT07046897
Analysis of the Gut Microbiota Composition After Consumption of Probiotic Bacteria
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
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.
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
Secondary outcomes
-
Relative abundance
Time frame: At enrollment and after 2 weeks of consumption.
Quantification of bacterial taxa will be calculated based on the results from next generation sequencing
Study contacts
Contact information is provided by the study sponsor or research team.
Rumathi de Mel, PhD-student
CONTACT
Åsa Håkansson, Associate Professor
CONTACT
Sponsors and collaborators
Lead sponsor
Lund University
Other
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Jul 2, 2025
- Registry last updated
- Jul 2, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.