Ignite Creation Date:
2024-05-06 @ 10:37 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03307772
Status:
COMPLETED
Last Update Posted:
2017-10-12
First Post:
2017-10-03
Brief Title:
Immune Response to the Consumption of Lactobacillus GG and FOS in Patients With Recurrent Herpes Labialis
Sponsor:
Sprim Advanced Life Sciences
Organization:
Sprim Advanced Life Sciences
Study Overview
Official Title:
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
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVIM
Brief 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- andor 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
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- andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None