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

Analysis of the Intestinal Flora Composition After Consumption of Water Kefir

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.

Study Overview

• Status: Recruiting
• Conditions: Probiotics; Healthy Diet; Gastrointestinal Microbiome
• Intervention / Treatment: Dietary supplement: Water Kefir beverage

• Study Type: Interventional
• Enrollment (Anticipated): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Lund, Skåne, Sweden, 22100
      • Recruiting
      • Lund University
      • Contact: Åsa Håkansson, PhD; Phone Number: +46704566277; Email: asa.hakansson@food.lth.se
      • Contact: Hanna L Bergström, Bachelor; Phone Number: +46706889308; Email: ha6076be-s@student.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Potential changes of microbiome after consumption of the water kefir will be assessed by analyzing the 16S metagenomics	up to 24 weeks

Collaborators and Investigators

• Sponsor: Lund University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Anticipated): January 14, 2023
• Study Completion (Anticipated): April 14, 2023

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: December 11, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 11, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Water Kefir

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No