Healthy DietNCT05657730
Study the Effect of Water Kefir Consumption on the Gut Microbiome in Healthy Adults
A study testing Water Kefir beverage in people with Healthy Diet and Gastrointestinal Microbiome, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet, Gastrointestinal Microbiome, Probiotics
- What is being tested?
- Water Kefir beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSweden
- Study dates
- 10 Nov 2022to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years of age.
- must be able to complete the form digitally.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Lund University
Lund, Skåne County, 22100
Åsa Håkansson, PhD, +46704566277, asa.hakansson@food.lth.se
Hanna L Bergström, Bachelor, +46706889308, ha6076be-s@student.lu.se
About this study
Official title: 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.
- Conditions
- Healthy Diet, Gastrointestinal Microbiome, Probiotics
- Being tested
- Water Kefir beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water Kefir beverageDietary supplement
Participants will consume the water kefir beverage for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Not described Receives: Dietary Supplement: Water Kefir beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start10 Nov 2022
- Primary completion14 Jan 2023 (estimated)
- Study completion14 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Åsa Håkansson, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657730
- Sponsor's protocol ID
- Water Kefir
- Status last verified
- Dec 2022
- First submitted
- 9 Nov 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Intestinal Flora Composition After Consumption of Water Kefir
- ClinicalTrials.gov ID
- NCT05657730
- Acronym / sponsor ID
- Water Kefir
- Conditions
- Healthy Diet, Gastrointestinal Microbiome, Probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 14 Jan 2023 (estimated)
- Study completion
- 14 Apr 2023 (estimated)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Dietary Supplement: Water Kefir beverage |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years of age.
- must be able to complete the form digitally.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water Kefir beverageParticipants will consume the water kefir beverage for two weeks. | Dietary supplement | Active group |
Primary outcome
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)
Time frame: up to 24 weeks
Potential changes of microbiome after consumption of the water kefir will be assessed by analyzing the 16S metagenomics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Kefir beverage in people with Healthy Diet and Gastrointestinal Microbiome, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.