A phase I/II, double blind, cross-over design, placebo controlled, pilot study to assess the effect and tolerability of multiple oral doses of phytosphingosine in Sjögren’s patients.

1. Primary Sjögren’s syndrome female adult patients, diagnosed following EU criteria [1];

2. Stimulated whole salivary flow rate >0.30 ml/min, stimulated parotid salivary >0.15 ml/min;

3. Saliva positive for S. mutants and C. albicans (all m.o. cfu≥103);

4. Not pregnant;

5. No use of xerogenic drugs or drugs that might affect oral ecology;

6. Willing and able to adhere to the study visit schedule and other protocol requirements;

7. Written informed consent signed.

1. Use of antibiotic medication less than 3 weeks before screening;

2. Dentures;

3. Smoking;

4. Current or history of drug and/or alcohol abuse;

5. In parallel participation in another trial with an investigational product.