Celiac DiseaseCeliKefNCT07777666
Effects of Kefir on Celiac Disease
A study testing kefir in people with Celiac Disease, run by University Maribor at 1 site in Slovenia.
Trial summary
This study will investigate whether regular consumption of kefir can reduce gastrointestinal symptoms and improve quality of life in adults with celiac disease who follow a strict gluten-free diet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease
- What is being tested?
- kefir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 30 Sep 2026to 29 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older with a confirmed diagnosis of celiac disease.
- Following a strict gluten-free diet.
Who cannot join
- Other chronic gastrointestinal diseases.
- Pregnancy.
- Known allergy or intolerance to milk or dairy products or other components of kefir.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site
University of Maribor, Faculty of Health Sciences
Maribor, 2000
SABINA FIJAN, PhD, +38623004755, sabina.fijan@um.si
About this study
Official title: Effects of Kefir Consumption on Celiac Disease Symptoms
This study will investigate whether regular consumption of kefir can reduce gastrointestinal symptoms and improve quality of life in adults with celiac disease who follow a strict gluten-free diet. The study will use a randomized cross-over design in which participants will consume kefir during one study period and continue their usual diet without kefir during another period.
Read the detailed description
Celiac disease is a chronic autoimmune disease triggered by gluten consumption. Although a strict gluten-free diet is the only established treatment, some individuals continue to experience gastrointestinal symptoms and reduced quality of life.
The CeliKef study will investigate whether regular consumption of kefir may help alleviate gastrointestinal symptoms and improve quality of life in adults with celiac disease following a strict gluten-free diet. The study will include approximately 30 participants and will use a randomized cross-over design. Each participant will undergo a kefir consumption period and a period without kefir, separated by a washout period. Gastrointestinal symptoms and celiac disease-related quality of life will be assessed during the study.
- Conditions
- Celiac Disease
- Being tested
- kefir
- Keywords
- celiac disease, kefir, gluten
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kefirDietary supplement
Participants will consume 200 mL kefir prepared from starter cultures daily for 4 weeks. The kefir will be provided for the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Kefir first | Experimental | Participants randomized to this sequence will consume kefir daily for 4 weeks, followed by a 4-week washout period and then 4 weeks of their usual gluten-free diet without kefir. Receives: Dietary Supplement: kefir |
| No Kefir First | Experimental | Participants randomized to this sequence will follow their usual gluten-free diet without kefir for 4 weeks, followed by a 4-week washout period and then 4 weeks of daily kefir consumption. Receives: Dietary Supplement: kefir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastrointestinal symptoms assessed by the Gastrointestinal Symptom Rating Scale (GSRS)
Change in GSRS score between the kefir consumption period and the period without kefir. The GSRS is a validated questionnaire assessing gastrointestinal symptoms.
Measured: Baseline, after each 4-week intervention period, and after the 4-week washout period
Secondary outcomes (3)
Celiac disease-related quality of life assessed by the Celiac Disease Quality of Life questionnaire (CD-QOL)
Change in CD-QOL score between the kefir consumption period and the period without kefir.
Measured: Baseline, after each 4-week intervention period, and after the 4-week washout period
Stool consistency assessed by the Bristol Stool Form Scale (BSFS)
Change in stool consistency assessed using the Bristol Stool Form Scale during the kefir consumption period compared with the period without kefir.
Time Frame
Measured: Baseline, after each 4-week intervention period, and after the 4-week washout period
Adherence to a gluten-free diet assessed by the Celiac Dietary Adherence Test (CDAT)
Change in CDAT score between the kefir consumption period and the period without kefir.
Measured: Baseline, after each 4-week intervention period, and after the 4-week washout period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion29 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned to one of two intervention sequences. Each participant will receive kefir consumption and a period of usual gluten-free diet without kefir, with a 4-week washout period between the two periods.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabina Fijan, University Maribor
- Investigators
- SABINA FIJAN, PhD, Principal investigator, University of Maribor, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777666
- Sponsor's protocol ID
- 038/2025/6297-3/900
- Acronym
- CeliKef
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- 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 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kefir Consumption on Celiac Disease Symptoms
- ClinicalTrials.gov ID
- NCT07777666
- Acronym / sponsor ID
- CeliKef / 038/2025/6297-3/900
- Conditions
- Celiac Disease
- Keywords
- celiac disease, kefir, gluten
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University MariborUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 29 Nov 2027 (estimated)
- First posted
- 20 Aug 2026 (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.
This study will investigate whether regular consumption of kefir can reduce gastrointestinal symptoms and improve quality of life in adults with celiac disease who follow a strict gluten-free diet. The study will use a randomized cross-over design in which participants will consume kefir during one study period and continue their usual diet without kefir during another period.
Detailed description
Celiac disease is a chronic autoimmune disease triggered by gluten consumption. Although a strict gluten-free diet is the only established treatment, some individuals continue to experience gastrointestinal symptoms and reduced quality of life.
The CeliKef study will investigate whether regular consumption of kefir may help alleviate gastrointestinal symptoms and improve quality of life in adults with celiac disease following a strict gluten-free diet. The study will include approximately 30 participants and will use a randomized cross-over design. Each participant will undergo a kefir consumption period and a period without kefir, separated by a washout period. Gastrointestinal symptoms and celiac disease-related quality of life will be assessed during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two intervention sequences. Each participant will receive kefir consumption and a period of usual gluten-free diet without kefir, with a 4-week washout period between the two periods.
| Arm | Type | Receives |
|---|---|---|
| Kefir first | Experimental | Dietary Supplement: kefirParticipants randomized to this sequence will consume kefir daily for 4 weeks, followed by a 4-week washout period and then 4 weeks of their usual gluten-free diet without kefir. |
| No Kefir First | Experimental | Dietary Supplement: kefirParticipants randomized to this sequence will follow their usual gluten-free diet without kefir for 4 weeks, followed by a 4-week washout period and then 4 weeks of daily kefir consumption. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 years or older with a confirmed diagnosis of celiac disease.
- Following a strict gluten-free diet.
Key exclusion criteria (3 listed)
- Other chronic gastrointestinal diseases.
- Pregnancy.
- Known allergy or intolerance to milk or dairy products or other components of kefir.
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 |
|---|---|---|
| kefirParticipants will consume 200 mL kefir prepared from starter cultures daily for 4 weeks. The kefir will be provided for the intervention period. | Dietary supplement | Kefir first, No Kefir First |
Primary outcome
Change in gastrointestinal symptoms assessed by the Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Baseline, after each 4-week intervention period, and after the 4-week washout period
Change in GSRS score between the kefir consumption period and the period without kefir. The GSRS is a validated questionnaire assessing gastrointestinal symptoms.
3 secondary outcomes
Celiac disease-related quality of life assessed by the Celiac Disease Quality of Life questionnaire (CD-QOL)
Time frame: Baseline, after each 4-week intervention period, and after the 4-week washout period
Stool consistency assessed by the Bristol Stool Form Scale (BSFS)
Time frame: Baseline, after each 4-week intervention period, and after the 4-week washout period
Adherence to a gluten-free diet assessed by the Celiac Dietary Adherence Test (CDAT)
Time frame: Baseline, after each 4-week intervention period, and after the 4-week washout period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- 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.
SABINA FIJAN, PhD principal investigator
University of Maribor, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kefir in people with Celiac Disease, run by University Maribor at 1 site in Slovenia.
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 3 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: opening soon, as of the sponsor's last update on 20 Aug 2026. 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 Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SABINA FIJAN, PhD (+38623004755, sabina.fijan@um.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gastrointestinal symptoms assessed by the Gastrointestinal Symptom Rating Scale (GSRS) (time frame: Baseline, after each 4-week intervention period, and after the 4-week washout period). 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 Aug 2026.