Health Trials

Effects of Kefir on Celiac Disease

ConditionCeliac Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Maribor

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older with a confirmed diagnosis of celiac disease.

Following a strict gluten-free diet.

Disqualifiers

Other chronic gastrointestinal diseases.

Pregnancy.

Known allergy or intolerance to milk or dairy products or other components of kefir.

Trial design

Design model

Crossover

Treatments tested in this trial

  • kefir

    Dietary supplement

    Participants will consume 200 mL kefir prepared from starter cultures daily for 4 weeks. The kefir will be provided for the intervention period.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Kefir firstExperimental treatment 1 intervention
Group B: No Kefir FirstExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Maribor

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: