Celiac Disease
Conditions
Keywords
celiac disease, kefir, gluten
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTkefir
Participants will consume 200 mL kefir prepared from starter cultures daily for 4 weeks. The kefir will be provided for the intervention period.
Sponsors
University Maribor
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older with a confirmed diagnosis of celiac disease. * Following a strict gluten-free diet.
Exclusion criteria
* Other chronic gastrointestinal diseases. * Pregnancy. * Known allergy or intolerance to milk or dairy products or other components of kefir.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in gastrointestinal symptoms assessed by the Gastrointestinal Symptom Rating Scale (GSRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Celiac disease-related quality of life assessed by the Celiac Disease Quality of Life questionnaire (CD-QOL) | Baseline, after each 4-week intervention period, and after the 4-week washout period | Change in CD-QOL score between the kefir consumption period and the period without kefir. |
| Stool consistency assessed by the Bristol Stool Form Scale (BSFS) | Baseline, after each 4-week intervention period, and after the 4-week washout period | Change in stool consistency assessed using the Bristol Stool Form Scale during the kefir consumption period compared with the period without kefir. Time Frame |
| Adherence to a gluten-free diet assessed by the Celiac Dietary Adherence Test (CDAT) | Baseline, after each 4-week intervention period, and after the 4-week washout period | Change in CDAT score between the kefir consumption period and the period without kefir. |
Countries
Slovenia
Contacts
CONTACTSABINA FIJAN, PhD
PRINCIPAL_INVESTIGATORSABINA FIJAN, PhD
University of Maribor, Faculty of Health Sciences
Outcome results
None listed