Abstract
Objectives:
The recurrent aphthous stomatitis (RAS) is a chronic oral inflammatory disease and it still poses as a clinical problem without satisfactory treatment. The aims of the study were: (1) Evaluate the clinical outcome of RAS patients towards the use of symbiotic Lactofos/Simbioflora, analyzing symptoms, seizure frequency, number, duration, and size of the lesions. (2) Compare the immune profile of RAS patients through cytokine levels with each other and controls before and after treatment.
Methods:
We conducted double blind randomized clinical trial placebo controlled study with 60 patients with RAS and 30 controls in a period of 2 years (2011-2012).
Results:
The symbiotic group showed improvement in pain compared with placebo (P = .027), with no statistical difference for the other clinical variables assessed. The side effects observed were similar in both groups, but flatulence (P = .003) and diarrhea (P = .04) were significant for the symbiotic group. Significant differences were found in cytokine IFN-Y, IL-4, and IL-6 in serum of peripheral blood mononuclear cells (PBMCs) of patients when compared with control and RAS groups. Regarding treatment over time we observed that IFN-Y (P = .023), IL-4 (P = .045), IL-10 (P = .000), and IL-12p70 (P = .027) showed significant difference or between treatments or during the time line.
Conclusions:
The symbiotic was effective in improving pain compared with placebo. Patients with RAS have a mixed profile of Th1/Th2 immune response when compared with the control group at baseline. The symbiotic induced Th1 and Th2 responses by increasing IL-12 and IFN-Y and IL-4 and IL-10, respectively.
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