An interventional study of kefir in Celiac Disease, sponsored by University Maribor. Not yet recruiting at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by University Maribor · Not applicable, Interventional, and Treatment
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.
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.
352 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 214 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →University Maribor is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
Dietary Supplement: kefir
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.
Dietary Supplement: kefir
Participants will consume 200 mL kefir prepared from starter cultures daily for 4 weeks. The kefir will be provided for the intervention period.
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.
Time frame: Baseline, after each 4-week intervention period, and after the 4-week washout period
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.
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)
Change in stool consistency assessed using the Bristol Stool Form Scale during the kefir consumption period compared with the period without kefir. Time Frame
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)
Change in CDAT score between the kefir consumption period and the period without kefir.
Time frame: Baseline, after each 4-week intervention period, and after the 4-week washout period
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for May 2027, 8 months later.
Of 82 non-industry interventional studies with no phase under Celiac Disease, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's planned 8 months is below that.
Counting every sponsor, half of 87 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Kefir
University Maribor