Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-01-02 @ 9:17 AM
Study NCT ID:
NCT03873350
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2019-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the Fermented Tea Beverage Kombucha on the Oral and Gut Microflora
Sponsor:
Lund University
Organization:
Study Overview
Official Title:
The Effect of the Fermented Tea Beverage Kombucha on the Human Microflora: a Placebo-controlled Study
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: