Recorrent oral aphthae
Conditions
Interventions
Test group 30 patients will receive 2 envelops per day with probiotic. The patient must intake the envelops during 120 days.
Control group: 30 patients will receive 2 envelops per day with placebo. Th
Drug
Sponsors
Universidade Federal de São Paulo
Universidade Federal de São Paulo
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Patients with a history of recurrent aphthous stomatitis (RAS) with age between 18 to 60 years, both genders; suffering from RAS for at least one year, with ulcers at least once a month; who had signed informed consent.
Exclusion criteria
Exclusion criteria: Patients with a history of EAR under age of 18 or over 60 years; chronic smokers or alcoholics ; pregnancy or it suspicion ; patients with current or previous malignancies ; undergoing chemotherapy or radiotherapy ; suspected or history of congenital or acquired immunodeficiency ; under suspected or history of Crohn's disease or other inflammatory bowel diseases ; suspected or history of periodic fever syndrome associated with aphthous stomatitis , pharyngitis and cervical adenitis ( PFAPA ) , Reiter's syndrome , or suspected Behcet's disease; suspected or history of any vitamin or nutritional deficiency , cyclic neutropenia , anemia and autoimunes diseases , chronic use of drugs such as nonsteroidal anti esterioidais , immunosuppressants ( azathioprine , cyclosporine , corticosteroids , interferons ) , anxiolytics , antidepressants or nicorandil ; diseases such as renal failure , liver failure , hyperthyroidism or hypothyroidism , in the use of any type of food with probiotics and fiber supplements and antidiarrheal medications or laxatives regularly.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the number of ulcers crisis; Reduction of painful symptoms (DOR) during crises assessed by visual analogue scale Reduction in mean time to repair lesions (measured in days) Reduction in lesion size (measured by ruler) Reduction in the cytokine levels: Th1 (IL12-p70, INF-g ) Increase in the cytokine levels: Th2 (IL10, IL4) Reduction in the cytokine levels: inflamatory (TNF-A, IL6, IL17), | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effect incidence Side effect type ;Incidence of side-effects flatulence and leaky gut. | — |
Countries
Brazil
Contacts
Public ContactMaria Angela;Ricardo Mimura;Borra
Universidade Federal de São Paulo;Universidade Federal de São Carlos – UFSCar
Outcome results
None listed