Treatment(Processing) of the oral aphtose récidivante and idiopathique of the adult by probiotics

Phase 1

• Conditions: aphtous stoma; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-003944-38-FR
• Lead Sponsor: CHU NICE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-18
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients older than 18 years old with recurrent and idiopathic aphtous stomatitis. They must have a medical history of recurrent minor aphthous ulcer for at least 6 months with a frequency of at least 1 flare per month
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Use of a probiotic for any other reason. Immunosuppression. Aphtous ulcers as manifestation of systemic disorders such as ulcerative colitis, Crohn disease, Behcet syndrome. Use of medications such as systemic steroids or immunomodulatory agents or colchicine during the last 3 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified