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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25165

Enrollment

Registered

2009-06-22

Start date

2009-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Xerostomia, Sjogren disease, Candida albicans, phytosphingosine

Interventions

Single treatment with pastilles containing phytosphingosine or placebo. Wash out period at least 14 days.

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Reduction in C. albicans and or S. mutans relative to control.	—

Secondary

Measure	Time frame
Tolerability.	—

Contacts

Public ContactA. Vissink

Section Oral & Maxillofacial Surgery University Medical Center Groningen Hanzeplein 1

g.j.dijkstra@med.umcg.nl+31(0)50 3613841

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)