Study the Effect of Water Kefir Consumption on the Gut Microbiome in Healthy Adults

Sponsor

Lund University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05657730

Collaborator

(none)

Enrollment

Location

Arm

5.1

Anticipated Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this intervention study is to analyse the microbiota composition after the water kefir consumption. The main questions are to evaluate the potential probiotic drink can have beneficial effect on the gut microbiota. Participants will consume the water kefir for two weeks and microbiota will be analysed. Researchers will compare the microbiota composition before and after consumption.

Condition or Disease	Intervention/Treatment	Phase
Healthy Diet Gastrointestinal Microbiome Probiotics	Dietary Supplement: Water Kefir beverage	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

63 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Analysis of the Intestinal Flora Composition After Consumption of Water Kefir

Actual Study Start Date :

Nov 10, 2022

Anticipated Primary Completion Date :

Jan 14, 2023

Anticipated Study Completion Date :

Apr 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active group	Dietary Supplement: Water Kefir beverage Participants will consume the water kefir beverage for two weeks.

Arm

Intervention/Treatment

Experimental: Active group

Dietary Supplement: Water Kefir beverage

Participants will consume the water kefir beverage for two weeks.

Outcome Measures

Primary Outcome Measures

16S metagenomics based measurement of the bacterial diversity (alpha- and beta diversity indices), and the composition (relative abundance of the bacterial taxa in each sample) [up to 24 weeks]
Potential changes of microbiome after consumption of the water kefir will be assessed by analyzing the 16S metagenomics

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18-65 years of age.
must be able to complete the form digitally.

Exclusion Criteria:

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.
must not take antibiotics during the study period.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lund University	Lund	Skåne	Sweden	22100

Sponsors and Collaborators

Lund University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Åsa Håkansson, Associate Professor, Lund University

ClinicalTrials.gov Identifier:

NCT05657730

Other Study ID Numbers:

Water Kefir

First Posted:

Dec 20, 2022

Last Update Posted:

Dec 20, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 20, 2022