J30
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Diagnosis of seasonal allergic rhinitis and/or conjunctivitis, with a VAS score of >=4 in response to the question: “Thinking back to past allergy seasons, how much did your allergy symptoms bother you when you were not taking medication?” - Willingness to consume the predetermined amount of sauerkraut or placebo daily - Consumption of a maximum of 2 additional portions of other fermented vegetables (whether pasteurized or unpasteurized) per week for at least 4 weeks before the start of the study until the end of the study - Written informed consent from the participant
Exclusion criteria
Exclusion criteria: - Presence of a chronic or acute illness other than allergy - Regular use of the following medications: Antibiotics, antidepressants, immunotherapy, antihistamines, immunomodulatory drugs (corticosteroids, other immune-modifying drugs), emergency medication is permitted - Pregnant or breastfeeding women - Intolerance to fermented foods, probiotics or cabbage - Use of probiotics, prebiotics or postbiotics - Consumption of 3 or more fermented foods per week within the last 4 weeks before the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Total Nose and Eye Symptom Scores (TNESS) after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in daily assessment of allergy symptoms and medication intake using the visual Analog Scale (via the MyCap application integrated in RedCap) in terms of mobile ecological momentary assessments (mEMA) - Change in quality of life using the WHOQOL-BREF - changes in gastrointestinal symptoms - Gastrointestinal Symptom Rating Scale (GSRS) - changes in stool consistency - changes in the Generalized Depression Scale (ADS) - changes in the Generalized Anxiety Disorder (GAD-7) scale - Changes in systemic inflammatory markers (CRP, IL6) and specific immune cell populations - Changes in functional and compositional markers of the gut microbiome (metagenome analysis) - Documentation of the consumption of emergency medication (e.g. antihistamines, corticosteroids) - Qualitative evaluation of written feedback from participants on their perception of the intervention - Perception of the nutritional intervention and possible hurdles by individual participants in individual interviews and focus group discussions | — |
Countries
Germany
Contacts
Charité Competence Center for Traditional and Integrative Medicine (CCCTIM)