The Effect of the Fermented Tea Beverage Kombucha on the Oral and Gut Microflora

NCT03873350 | Completed

• 1 other identifier: Kombucha study 2018
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbial Colonization

Keywords

Microbiota colonization kombucha bacteria yeast

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Samples will be collected before, directly after and ten days after the intervention. The kombucha culture is studied before the intervention.

Study Arms (3)

Living kombucha

EXPERIMENTAL

Other: Consumption of kombucha

Heat-sterilized kombucha

PLACEBO COMPARATOR

Other: Consumption of heat-sterilized kombucha

Water

NO INTERVENTION

Interventions

Consumption of kombucha OTHER

The intervention performed in the study implies letting healthy individuals consume one bottle (33 cl) of living kombucha daily for three weeks.

Living kombucha

Consumption of heat-sterilized kombucha OTHER

The intervention performed in the study implies letting healthy individuals consume one bottle (33 cl) of heat-sterilized kombucha daily for three weeks.

Heat-sterilized kombucha

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Lund University

Lund, Skåne County, 22100, Sweden

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participants will be masked, meaning they will not know if they are given living or sterilized kombucha. The control group consuming water will know that they are the control group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant university lecturer at the Department of Food Technology, Lund University

Model Details: 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).

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: April 1, 2018
• Primary Completion: May 2, 2018
• Study Completion: May 4, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)