The influence of kefir consumption on the intestinal microbiome of healthy adults – a pilot study

Not Applicable

Completed

• Conditions: Prevention of gastrointestinal disease; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12621001558819
• Lead Sponsor: Southern Cross University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-17
• Study Completion: 2023-10-20
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Healthy
BMI 18.5-29.9

Exclusion Criteria

- Acute illness (injury, infection)
- Chronic gastrointestinal conditions (inflammatory or functional bowel diseases, celiac disease, food intolerance or allergies (especially milk), lactose intolerance
- Use of long-term medication
- Use of antimicrobial medication (incl. antibiotics) in the previous 6 months
- Regular use of pre-, pro-, or synbiotics in the previous 6 months, specifically natural yogurt, probiotic drinks, or products (at least once weekly)
- Consumption of fermented foods for health purpose within the last 2 months, specifically kefir, sauerkraut, kombucha, miso, kimchi (occasional consumption is acceptable)
- Diet prescribed for medical purposes
- Recent lifestyle changes (including new dietary regimen, or uptake of exercise regimen)
- Women currently undergoing menopause, and women who are pregnant, or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oral microbiome profile<br>Saliva swabs will be assessed using Amplicon Sequencing – 16S to determine the oral microbial profile[ 14 days post-commencement of intervention];Gut microbiome profile<br>Stool samples will be assessed using Amplicon Sequencing – 16S to determine the gut microbial profile[ 14 days post-commencement of intervention]

Secondary Outcome Measures

Name	Time	Method
Oral microbiome profile<br>Saliva swabs will be assessed using Amplicon Sequencing – 16S to determine the oral microbial profile[ 28 days post-commencement of intervention];Gut microbiome profile<br>Stool samples will be assessed using Amplicon Sequencing – 16S to determine the gut microbial profile[ 28 days post-commencement of intervention];Compliance via consumption of recommended doses, data collected via participant diary[ Daily from baseline to 14 days post-commencement of intervention];Acceptability via participant feedback, open question on participant's experiences with the trial intervention[ Daily from baseline to 14 days post-commencement of intervention];Safety via adverse events (diary, phone interview)[ 14 days, and 28 days after commencement of the intervention];Safety via gastrointestinal symptoms (Structured Assessment of Gastrointestinal Symptoms instrument - SAGIS, Koloski et al., 2017)[ 14 days, and 28 days after commencement of the intervention]