Microbiota Analysis in Healthy SubjectsNCT07046897
Analysis of the Gut Microbiota Composition After Consumption of Probiotic Bacteria
A study testing Consumption of probiotics strain 5 and Consumption of probiotics strain 6 in people with Microbiota Analysis in Healthy Subjects, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota Analysis in Healthy Subjects
- What is being tested?
- Consumption of probiotics strain 5 and Consumption of probiotics strain 6
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 12 Nov 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- You must be 18-65 years of age.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rumathi de Mel, PhD-student contact
Sweden1 site, 1 recruiting
- Recruiting
Department of Process and Life Science Engineering, Lund University
Lund, 22100
Mattias Alveteg, Head of department, mattias.alveteg@ple.lth.se
About this study
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.
Read the 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.
- Conditions
- Microbiota Analysis in Healthy Subjects
- Being tested
- Consumption of probiotics strain 5, Consumption of probiotics strain 6
- Keywords
- Probiotics, Microbiota composition, Saliva, Faeces, Healthy individuals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of probiotics strain 5Dietary supplement
Consumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 5.
Consumption of probiotics strain 6Dietary supplement
Consumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 6.
| Study group | Role | What they receive |
|---|---|---|
| Consumption of probiotics strain 5 | Experimental | The participants will consume a probiotic product, a capsule with freeze-dries bacteria (B. coagulans strain 5). Receives: Dietary Supplement: Consumption of probiotics strain 5 |
| Consumption of probiotics strain 6 | Experimental | The participants will consume a probiotic product, a capsule with freeze-dries bacteria (B. coagulans strain 6). Receives: Dietary Supplement: Consumption of probiotics strain 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The gut microbiota composition
Diversity index will be calculated based on the results from next generation sequencing
Measured: 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
Measured: At enrollment and after 2 weeks of consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start12 Nov 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbiota Analysis in Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Åsa Håkansson, Associate Professor, Principal investigator, Lund University, LTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046897
- Sponsor's protocol ID
- Lund University, LTH
- Status last verified
- Jun 2025
- First submitted
- 7 Jan 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Gut Microbiota Composition After Consumption of Probiotic Bacteria
- ClinicalTrials.gov ID
- NCT07046897
- Acronym / sponsor ID
- Lund University, LTH
- Conditions
- Microbiota Analysis in Healthy Subjects
- Keywords
- Probiotics, Microbiota composition, Saliva, Faeces, Healthy individuals
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consumption of probiotics strain 5 | Experimental | Dietary Supplement: Consumption of probiotics strain 5The participants will consume a probiotic product, a capsule with freeze-dries bacteria (B. coagulans strain 5). |
| Consumption of probiotics strain 6 | Experimental | Dietary Supplement: Consumption of probiotics strain 6The participants will consume a probiotic product, a capsule with freeze-dries bacteria (B. coagulans strain 6). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- You must be 18-65 years of age.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consumption of probiotics strain 5Consumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 5. | Dietary supplement | Consumption of probiotics strain 5 |
| Consumption of probiotics strain 6Consumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 6. | Dietary supplement | Consumption of probiotics strain 6 |
Primary outcome
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
1 secondary outcome
Relative abundance
Time frame: At enrollment and after 2 weeks of consumption.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rumathi de Mel, PhD-student contact
Åsa Håkansson, Associate Professor principal investigator
Lund University, LTH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption of probiotics strain 5 and Consumption of probiotics strain 6 in people with Microbiota Analysis in Healthy Subjects, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Åsa Håkansson, Associate Professor (+46 46 2228326, asa.hakansson@ple.lth.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The gut microbiota composition (time frame: At enrollment and after 2 weeks of consumption.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.