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Analysis of the Gut Microbiota Composition After Consumption of Probiotic Bacteria

Analysis of the Gut Microbiota Composition After Consumption of Probiotic Bacteria

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07046897
Enrollment
60
Registered
2025-07-02
Start date
2024-11-12
Completion date
2025-06-30
Last updated
2025-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbiota Analysis in Healthy Subjects

Keywords

Probiotics, Microbiota composition, Saliva, Faeces, Healthy individuals

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.

Interventions

DIETARY_SUPPLEMENTConsumption of probiotics strain 5

Consumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 5.

DIETARY_SUPPLEMENTConsumption of probiotics strain 6

Consumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 6.

Sponsors

Lund University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
The gut microbiota compositionAt enrollment and after 2 weeks of consumption.Diversity index will be calculated based on the results from next generation sequencing

Secondary

MeasureTime frameDescription
Relative abundanceAt enrollment and after 2 weeks of consumption.Quantification of bacterial taxa will be calculated based on the results from next generation sequencing

Countries

Sweden

Contacts

Primary ContactÅsa Håkansson, Associate Professor
asa.hakansson@ple.lth.se+46 46 2228326
Backup ContactRumathi de Mel, PhD-student
rumathi.de_mel@ple.lth.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026