- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03873350
The Effect of the Fermented Tea Beverage Kombucha on the Oral and Gut Microflora
The Effect of the Fermented Tea Beverage Kombucha on the Human Microflora: a Placebo-controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Skåne
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Lund, Skåne, Sweden, 22100
- Lund University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Living kombucha
|
The intervention performed in the study implies letting healthy individuals consume one bottle (33 cl) of living kombucha daily for three weeks.
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Placebo Comparator: Heat-sterilized kombucha
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The intervention performed in the study implies letting healthy individuals consume one bottle (33 cl) of heat-sterilized kombucha daily for three weeks.
|
No Intervention: Water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Samples will be collected before, directly after and ten days after the end of the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
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Samples will be collected before, directly after and ten days after the intervention. The kombucha culture is studied before the intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kombucha study 2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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