NCT03307772

Immune Response to the Consumption of Lactobacillus GG and FOS in Patients With Recurrent Herpes Labialis

A Randomized, Triple-blind Placebo-controlled Single Center Trial to Evaluate the Immune Response to the Consumption of a Minidrink Containing a Combination of Lactobacillus GG and Fructooligosaccharides in Patients With Recurrent Herpes Labialis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Sprim Advanced Life Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Herpes Labialis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotics
DIETARY_SUPPLEMENT	Prebiotics
DIETARY_SUPPLEMENT	Prebiotics and Probiotics
DIETARY_SUPPLEMENT	Placebo

Timeline

• Start date: 2008-12-15
• Primary completion: 2009-09-16
• Completion: 2009-10-20
• First posted: 2017-10-12
• Last updated: 2017-10-12