Microbial ColonizationNCT03873350
The Effect of the Fermented Tea Beverage Kombucha on the Oral and Gut Microflora
A study testing Consumption of kombucha and Consumption of heat-sterilized kombucha in people with Microbial Colonization, run by Lund University at 1 site in Sweden.
Trial summary
The purpose of the project is to investigate if consumption of the fermented tea beverage kombucha has an effect on the gut and/or oral microbiota, and further if it depends on the content of living bacteria or is inherent even to sterilized kombucha. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Consumption of kombucha and Consumption of heat-sterilized kombucha
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2018to 4 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participants should be above 18 years of age.
- The participants must live in proximity of Lund or Helsingborg to be able to leave samples collected.
- The participants should consider themselves healthy and have no gut or stomach problems.
Who cannot join
- The participants should not be diagnosed with any gut or stomach diseases or problems.
- The participants cannot consume any food with living microorganisms two weeks before, during of ten days after the intervention.
- Participants cannot use anti-microbial oral products during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Fermented Tea Beverage Kombucha on the Human Microflora: a Placebo-controlled Study
The purpose of the project is to investigate if consumption of the fermented tea beverage kombucha has an effect on the gut and/or oral microbiota, and further if it depends on the content of living bacteria or is inherent even to sterilized kombucha. This will be studied by a clinical trial in which healthy individuals will be given living kombucha, sterilized kombucha or water. The participants will consume one bottle (33 cl) of their designated drink per day for 21 days. Fecal and saliva samples will be collected before, directly and ten days after the intervention. These will then be examined to see if there is a change in the micro flora due to the kombucha.
Read the detailed description
The first part of the project focuses on studying the characteristics of the kombucha drink and microbial composition. The amount of living organisms in the drink will be determined by colony count. Apart from this, the culture will be studied to determine which organisms are present and which are dominant. After isolation of colonies found from culturing, Sanger sequencing will be used for characterization.
The second part, which consists of the human study, will be performed over a span of 3 weeks and the aim is that 60 persons take part. The participants should be healthy, and have no diagnosed gut or stomach problems, and be 18 years old or older. They will be divided into groups, where one will be given living kombucha, one group kombucha sterilized by boiling (placebo) and the final group plain water (control group). The participants will drink one bottle (33 cl) of their designated beverage daily for two weeks. Fecal and saliva samples will be collected before, directly after and 10 days after the intervention. The samples will then be studied by sequencing the present organisms, after having extracted them. The library preparation will be made using Illumina sequencing. If possible, the aim is also to re-isolate a species from the kombucha after the study.
The participants will be registered for the study as they sign a consent form. These forms will then be treated as confidential material, and therefore be kept locked away at the institution. Only participating researchers will have access to the forms.
The participants will store the samples collected during the study until they are handed in for analysis. The samples will be destroyed during analysis.
The sample size has been chosen to a maximum of 60 participants, due to economical boundaries, but mainly because similar studied have used even fewer participants. As this is a pilot study more is not necessary. The intervention time (three weeks) was determined by comparison to other studies, but also restricted by the time scope of the project.
- Conditions
- Microbial Colonization
- Being tested
- Consumption of kombucha, Consumption of heat-sterilized kombucha
- Keywords
- Microbiota colonization kombucha bacteria yeast
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of kombuchaOther
The intervention performed in the study implies letting healthy individuals consume one bottle (33 cl) of living kombucha daily for three weeks.
Consumption of heat-sterilized kombuchaOther
The intervention performed in the study implies letting healthy individuals consume one bottle (33 cl) of heat-sterilized kombucha daily for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Living kombucha | Experimental | Not described Receives: Other: Consumption of kombucha |
| Heat-sterilized kombucha | Placebo comparator | Not described Receives: Other: Consumption of heat-sterilized kombucha |
| Water | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is a change in the composition of the gut of oral micro flora, measured by extraction and sequencing of genetic material in fecal and saliva samples.
A library will be created using Illumina sequencing that will enable comparing the microbiological composition before and after the intervention.
Measured: Samples will be collected before, directly after and ten days after the end of the intervention.
Secondary outcomes (1)
The secondary outcome of the study is to be able to re-isolate a species from the kombucha in the collected samples after the intervention.
The secondary outcome will be measured by comparing results from the sequencing of microbes in the collected human samples and from the kombucha drink itself.
Measured: Samples will be collected before, directly after and ten days after the intervention. The kombucha culture is studied before the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 Apr 2018
- Primary completion2 May 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be divided into three groups in which one is given living kombucha, one heat-sterilized kombucha (placebo group) and one regular tap water (control group).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Åsa Håkansson, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873350
- Sponsor's protocol ID
- Kombucha study 2018
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share participant data.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Fermented Tea Beverage Kombucha on the Human Microflora: a Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03873350
- Acronym / sponsor ID
- Kombucha study 2018
- Conditions
- Microbial Colonization
- Keywords
- Microbiota colonization kombucha bacteria yeast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 13 Mar 2019 (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 purpose of the project is to investigate if consumption of the fermented tea beverage kombucha has an effect on the gut and/or oral microbiota, and further if it depends on the content of living bacteria or is inherent even to sterilized kombucha. This will be studied by a clinical trial in which healthy individuals will be given living kombucha, sterilized kombucha or water. The participants will consume one bottle (33 cl) of their designated drink per day for 21 days. Fecal and saliva samples will be collected before, directly and ten days after the intervention. These will then be examined to see if there is a change in the micro flora due to the kombucha.
Detailed description
The first part of the project focuses on studying the characteristics of the kombucha drink and microbial composition. The amount of living organisms in the drink will be determined by colony count. Apart from this, the culture will be studied to determine which organisms are present and which are dominant. After isolation of colonies found from culturing, Sanger sequencing will be used for characterization.
The second part, which consists of the human study, will be performed over a span of 3 weeks and the aim is that 60 persons take part. The participants should be healthy, and have no diagnosed gut or stomach problems, and be 18 years old or older. They will be divided into groups, where one will be given living kombucha, one group kombucha sterilized by boiling (placebo) and the final group plain water (control group). The participants will drink one bottle (33 cl) of their designated beverage daily for two weeks. Fecal and saliva samples will be collected before, directly after and 10 days after the intervention. The samples will then be studied by sequencing the present organisms, after having extracted them. The library preparation will be made using Illumina sequencing. If possible, the aim is also to re-isolate a species from the kombucha after the study.
The participants will be registered for the study as they sign a consent form. These forms will then be treated as confidential material, and therefore be kept locked away at the institution. Only participating researchers will have access to the forms.
The participants will store the samples collected during the study until they are handed in for analysis. The samples will be destroyed during analysis.
The sample size has been chosen to a maximum of 60 participants, due to economical boundaries, but mainly because similar studied have used even fewer participants. As this is a pilot study more is not necessary. The intervention time (three weeks) was determined by comparison to other studies, but also restricted by the time scope of the project.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The participants will be divided into three groups in which one is given living kombucha, one heat-sterilized kombucha (placebo group) and one regular tap water (control group).
| Arm | Type | Receives |
|---|---|---|
| Living kombucha | Experimental | Other: Consumption of kombucha |
| Heat-sterilized kombucha | Placebo comparator | Other: Consumption of heat-sterilized kombucha |
| Water | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The participants should be above 18 years of age.
- The participants must live in proximity of Lund or Helsingborg to be able to leave samples collected.
- The participants should consider themselves healthy and have no gut or stomach problems.
Key exclusion criteria (3 listed)
- The participants should not be diagnosed with any gut or stomach diseases or problems.
- The participants cannot consume any food with living microorganisms two weeks before, during of ten days after the intervention.
- Participants cannot use anti-microbial oral products 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 kombuchaThe intervention performed in the study implies letting healthy individuals consume one bottle (33 cl) of living kombucha daily for three weeks. | Other | Living kombucha |
| Consumption of heat-sterilized kombuchaThe intervention performed in the study implies letting healthy individuals consume one bottle (33 cl) of heat-sterilized kombucha daily for three weeks. | Other | Heat-sterilized kombucha |
Primary outcome
The primary outcome is a change in the composition of the gut of oral micro flora, measured by extraction and sequencing of genetic material in fecal and saliva samples.
Time frame: Samples will be collected before, directly after and ten days after the end of the intervention.
A library will be created using Illumina sequencing that will enable comparing the microbiological composition before and after the intervention.
1 secondary outcome
The secondary outcome of the study is to be able to re-isolate a species from the kombucha in the collected samples after the intervention.
Time frame: Samples will be collected before, directly after and ten days after the intervention. The kombucha culture is studied before the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: No. No plan to share participant data.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 kombucha and Consumption of heat-sterilized kombucha in people with Microbial Colonization, 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 3 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: finished, as of the sponsor's last update on 13 Mar 2019. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is a change in the composition of the gut of oral micro flora, measured by extraction and sequencing of genetic material in fecal and saliva samples. (time frame: Samples will be collected before, directly after and ten days after the end of the intervention.). 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 13 Mar 2019.