An interventional study of Probiotics and Prebiotics in Herpes Labialis, sponsored by Sprim Advanced Life Sciences. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-12.
Sponsored by Sprim Advanced Life Sciences · Not applicable, Interventional, and Treatment
Background: Herpes labialis is the result of the presence of Herplex Simplex Virus -1 (HSV-1) and is a common disease in the population. Because of its visibility it has a serious impact on social life and the feeling of well-being in people who suffer from this disease. Until now there is no effective treatment and no remedy for prevention of the virus outbreak.
Prebiotics and probiotics have both been shown to have a favorable and supportive effect on the immune system in different health conditions such as influenza, atopic dermatitis and diarrhea. So far no study has addressed the effect of the consumption of pre- and/or probiotics in a population with recurrent herpes labialis.
Aim of the study: The present study investigated the effect of pre- or probiotics or a combination of the two on the recurrence of herpes labialis lesions as well as on the immune system in general.
Design: 78 Patients were eligible to participate in the study and after a run-in period of two weeks consuming a placebo minidrink were randomized to one of the four experimental groups, these were: placebo minidrink (n=), prebiotic (fructooligosaccharides) minidrink (n=), probiotic (Lactobacillus rhamnosus GG or LGG) minidrink (n=) or a minidrink containing a combination of a pre- and probiotic. These minidrinks were consumed for another 5 weeks. At day 33 of the study the lip most prone to the development of a lesion was stimulated with UVB in order to provoke a lesion. During the entire study period subjects were checked for any clinical signs of a lesion, completed a self-assessment regarding the lesion and a quality of life questionnaire at baseline (day 14) and the end of the study (day 49). In addition, a blood sample was collected at baseline and at the end of the study to be analyzed for general and HSV-specific antibodies, intracellular cytokine concentrations and parameters of the innate immune response such as natural killer cell activity and phagocytosis.
The present study showed that the daily consumption of a minidrink containing either only Lactobacillus rhamnosus or a combination of Lactobacillus rhamnosus and fructooligosaccharides significantly decreased both the occurrence and the incidence of Herpes labialis lesions after stimulation with UVR in a population with recurrent Herpes labialis. No difference in the function of either CD8+ T lymphocytes or natural killer cells was found, nevertheless a trend, that did not reach statistical significance, was observed for some of the immunological analyses pointing out towards an immunemodulating effect of probiotic or pre- and probiotic combination minidrink on the adaptive immune system. The end of study results of immune analyses were slightly improved compared to the baseline values in individuals using the probiotics or the pre- and probiotics combination minidrink, however the differences between groups did not reach the significance level. Phagocytosis and killing were clearly and statistically different in individuals that used either placebo or probiotics or pre- and probiotics minidrinks. Therefore, the probiotics and the pre- and probiotics minidrinks have an important effect on innate immunity, resulting in a significant improvement of both phagocytosis and killing. No effect was found on the quality of life of subjects. No special or unusual features of the safety evaluations were found. No serious adverse events were reported during the study.
Exclusion Criteria:
The placebo drink consists of fermented low-fat milk with no added Lactobacillus GG.(placebo)
Dietary Supplement: Placebo
The probiotic drink consists of fermented low-fat milk with added Lactobacillus GG. (probiotics)
Dietary Supplement: Probiotics
The prebiotics drink consists of fermented low-fat milk with fructooligosaccharides. (prebiotics)
Dietary Supplement: Prebiotics
The probiotics and prebiotics drink consists of acidified low-fat milk with added Lactobacillus GG and fructooligosaccharides (prebiotics and probiotics)
Dietary Supplement: Prebiotics and Probiotics
Incidence rate of ultraviolet exposure-lesion
Incidence rate of ultraviolet exposure-lesion at at Day 42.
Time frame: Day 42
Incidence rate of ultraviolet exposure-lesion
Incidence rate of ultraviolet exposure-lesion at at Day 35.
Time frame: day 35
Incidence rate of ultraviolet exposure-lesion
Incidence rate of ultraviolet exposure-lesion at at Day 49
Time frame: day 49
Measurement of lesion size (mm2).
Measurement of lesion size as a product of the length and the width of the lesion (measured in mm2) at Day 35 / 42 / 49.
Time frame: Day 35 day 42 Day 49
Time to healing (days).
Time to healing defined as either loss of the hard crust or return to normal skin (measured in days) at Day 35 / 42 / 49
Time frame: Day 35 day 42 Day 49
Lesion development by classification of lesion stage.
Lesion development by classification of lesion stage. The lesion stages are shown in table 2 of the clinical protocol (adapted from Spruance et al, 2002). In addition, a photo was made at every visit. At Day 35 / 42 / 49
Time frame: Day 35 day 42 Day 49
Duration and intensity of pain (10 cm Vas Analogue Scale).
Duration and intensity of pain as recorded by the patient on a visual analogue scale (VAS) of 100 mm, at Day 35 / 42 / 49.
Time frame: Day 35 day 42 Day 49
Change in HSV-specific IgG, IgG3, IgG4 and IgE concentrations
HSV-specific IgG1 and IgG3 (Th1) and IgG4 and IgE (Th2) concentrations were analyzed by ELISA at day 49.
Time frame: Day 49
Change in HSV-specific CD8+ T cells by pentamers
Immunologic evaluation of HSV-specific CD8+ T cells by pentamers (only on HLA A2-01+ individuals: an estimated 35-40% of individuals fit this criterion) at day 49.
Time frame: Day 49
Change in HSV-specific CD8+ T cells by IFN-gamma ELISPOT
Immunologic evaluation of HSV-specific CD8+ T cells by IFN-gamma ELISPOT (only on HLA A2-01+ individuals: an estimated 35-40% of individuals fit this criterion) at day 49.
Time frame: day 49
Change in lytic ability of CD8+ T cells
Immunologic evaluation of the lytic ability of CD8+ T cells by FACS analyses (perforin, granzymes) (all individuals).
Time frame: day 49
Change in IL-2, IFN-γ, IL10
The following intracellular cytokine concentrations in HSV-stimulated CD4+ cells at day 49: * Interleukin-2; * Interferon-γ; * Interleukin-10.
Time frame: day 49
Change in SF-36 QoL questionnaire.
The quality of life was determined by the SF-36 quality of life questionnaire at day 49.
Time frame: day 49
Change in Phagocyte number and activity
Phagocyte number and activity as measured by flow cytometry;
Time frame: day 49
Change in NK cell number and activity
Natural killer cell number and activity as measured by flow cytometry.
Time frame: day 49
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