Ignite Creation Date:
2024-05-06 @ 10:38 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03310294
Status:
COMPLETED
Last Update Posted:
2017-10-16
First Post:
2017-10-04
Brief Title:
Immune Evidence to the Consumption of Lactobacillus GG and FOS Consumption in Patients With Herpes Labialis
Sponsor:
Sprim Advanced Life Sciences
Organization:
Sprim Advanced Life Sciences
Study Overview
Official Title:
A Randomized Double Blind Placebo-controlled Multicenter Clinical Study to Evaluate the Effect of a Combination of Probiotics and Prebiotics in Subjects 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:
EVIM2
Brief Summary:
Herpes labialis HL is the result of the presence of a virus called HSV-1 and is a common disease Because of its visibility due to cold sores it has a serious impact on social life Until now there is no effective treatment to prevent virus outbreaks However 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 it is possible that they are able to have a favourable effect also on HL
A recently completed pilot clinical trial Protocol Number 08-SBUS-2-GRA-01 EVIM-1 was completed using a fermented milk minidrink containing a combination of L rhamnosus and FOS it showed promising results in the reduction of HL recurrences in a population of 78 subjects with HSV-1 The study investigated the effect of pre- or probiotics or a combination of the two on the recurrence of HL lesions as well as on the immune system in general showing that the consumption of a minidrink containing the probiotic L rhamnosus or a minidrink containing a combination of L rhamnosus and FOS reduced the occurrence and the incidence of recurrent HL lesions
Aim of this study corroborate whether the consumption of a minidrink containing a combination of L rhamnosus and FOS results in less recurrence and a better progression of HL lesion in a larger population In addition the response of the consumption of the minidrink on the QoL and the response on immunity specific biomarkers were evaluated
Design 152 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 two experimental study groups placebo minidrink n79 and a minidrink containing a combination of a pre- and probiotic n78 These minidrinks were consumed until the end of the study day 140 At day 33 of the study the lip most prone to the development of a lesion was stimulated with UVB 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 QoL questionnaire at baseline day 14 at day 49 and the end of the study day 140 In addition a blood sample was collected at baseline at day 49 and at the end of the study to be analyzed for HSV-specific antibody concentrations to check immune system specific functions
A recently completed pilot clinical trial Protocol Number 08-SBUS-2-GRA-01 EVIM-1 was completed using a fermented milk minidrink containing a combination of L rhamnosus and FOS it showed promising results in the reduction of HL recurrences in a population of 78 subjects with HSV-1 The study investigated the effect of pre- or probiotics or a combination of the two on the recurrence of HL lesions as well as on the immune system in general showing that the consumption of a minidrink containing the probiotic L rhamnosus or a minidrink containing a combination of L rhamnosus and FOS reduced the occurrence and the incidence of recurrent HL lesions
Aim of this study corroborate whether the consumption of a minidrink containing a combination of L rhamnosus and FOS results in less recurrence and a better progression of HL lesion in a larger population In addition the response of the consumption of the minidrink on the QoL and the response on immunity specific biomarkers were evaluated
Design 152 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 two experimental study groups placebo minidrink n79 and a minidrink containing a combination of a pre- and probiotic n78 These minidrinks were consumed until the end of the study day 140 At day 33 of the study the lip most prone to the development of a lesion was stimulated with UVB 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 QoL questionnaire at baseline day 14 at day 49 and the end of the study day 140 In addition a blood sample was collected at baseline at day 49 and at the end of the study to be analyzed for HSV-specific antibody concentrations to check immune system specific functions
Detailed Description:
Background Herpes labialis is the result of the presence of HSV-1 and is a common disease Because of its visibility it has a serious impact on social life Until now there is no effective treatment to prevent virus outbreaks However 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
A recently completed pilot clinical trial Protocol Number 08-SBUS-2-GRA-01 EVIM-1 parallel groups placebo controlled triple blind single center randomized study with a fermented milk minidrink containing a combination of L rhamnosus and FOS showed promising results in the reduction of HL recurrences in a population of 78 subjects with HSV-1 the study investigated the effect of pre- or probiotics or a combination of the two on the recurrence of HL lesions as well as on the immune system in general showing that the consumption of a minidrink containing the probiotic L rhamnosus or a minidrink containing a combination of L rhamnosus and FOS reduced the occurrence and the incidence of recurrent HL lesions
Aim of the study corroborate whether the consumption of a minidrink containing a combination of L rhamnosus and FOS results in less recurrence and a better progression of HL lesion in a larger population In addition the response of the consumption of the minidrink on the QoL and the response on immunity specific biomarkers were evaluated
Design 152 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 two experimental study groups placebo minidrink n79 and a minidrink containing a combination of a pre- and probiotic n78 These minidrinks were consumed until the end of the study day 140 At day 33 of the study the lip most prone to the development of a lesion was stimulated with UVB 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 QoL questionnaire at baseline day 14 at day 49 and the end of the study day 140 In addition a blood sample was collected at baseline at day 49 and at the end of the study to be analyzed for HSV-specific antibody concentrations circulating concentrations of IgG1 and IgG3 Th1 and IgG4 Th2 NK activity CXCL10 analyzed by ELISA at days 14 49 and 140
as regards the primary endpoint results have shown that there was a significant decrease 543 in the recurrences of Herpes labialis lesions post UV stimulation at day 49 V4 compared to placebo in the PP population with consumption of the study product minidrink with fermented low fat milk added with Lactobacillus rhamnosus and FOS Considering the secondary endpoints in the PP population considering the number of subjects who presented lesions between V0 and V5 the number of lesions is reduced significantly both statistically and clinically in the treatment group compared to the placebo group There was a decrease in the lesion size in the treatment group when compared to placebo although the statistical significance is marginal As regards Subjective assessment of pain evaluated by means of a VAS scale significant pain reduction was found in the treatment group compared to the placebo group As regards immunological parameters was shown an increase in CXCL10 at V4 in the study group compared to the placebo group As regards IgG1 IgG3 and IgG4 V0 V4 and V5 although substantial increases were registered for some of these parameters these were not sufficient to describe a definite trend The natural killer NK cell activity did not show significant difference in their functional activity in the treatment group as compared to the placebo group
It has been verified through quality of life questionnaire SF-36 questionnaire that treatment improved Mental Health in the treatment group Nervous Peaceful Happy Down in Dumps Sad compared to the placebo group and clinical significance was found at V4 and V5 General Health and Vitality has been improved at V4 and V5
For each trial participant the adverse eventsserious adverse events occurrences and a brief clinical examination were assessed No special or unusual features of the safety evaluations were found
A recently completed pilot clinical trial Protocol Number 08-SBUS-2-GRA-01 EVIM-1 parallel groups placebo controlled triple blind single center randomized study with a fermented milk minidrink containing a combination of L rhamnosus and FOS showed promising results in the reduction of HL recurrences in a population of 78 subjects with HSV-1 the study investigated the effect of pre- or probiotics or a combination of the two on the recurrence of HL lesions as well as on the immune system in general showing that the consumption of a minidrink containing the probiotic L rhamnosus or a minidrink containing a combination of L rhamnosus and FOS reduced the occurrence and the incidence of recurrent HL lesions
Aim of the study corroborate whether the consumption of a minidrink containing a combination of L rhamnosus and FOS results in less recurrence and a better progression of HL lesion in a larger population In addition the response of the consumption of the minidrink on the QoL and the response on immunity specific biomarkers were evaluated
Design 152 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 two experimental study groups placebo minidrink n79 and a minidrink containing a combination of a pre- and probiotic n78 These minidrinks were consumed until the end of the study day 140 At day 33 of the study the lip most prone to the development of a lesion was stimulated with UVB 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 QoL questionnaire at baseline day 14 at day 49 and the end of the study day 140 In addition a blood sample was collected at baseline at day 49 and at the end of the study to be analyzed for HSV-specific antibody concentrations circulating concentrations of IgG1 and IgG3 Th1 and IgG4 Th2 NK activity CXCL10 analyzed by ELISA at days 14 49 and 140
as regards the primary endpoint results have shown that there was a significant decrease 543 in the recurrences of Herpes labialis lesions post UV stimulation at day 49 V4 compared to placebo in the PP population with consumption of the study product minidrink with fermented low fat milk added with Lactobacillus rhamnosus and FOS Considering the secondary endpoints in the PP population considering the number of subjects who presented lesions between V0 and V5 the number of lesions is reduced significantly both statistically and clinically in the treatment group compared to the placebo group There was a decrease in the lesion size in the treatment group when compared to placebo although the statistical significance is marginal As regards Subjective assessment of pain evaluated by means of a VAS scale significant pain reduction was found in the treatment group compared to the placebo group As regards immunological parameters was shown an increase in CXCL10 at V4 in the study group compared to the placebo group As regards IgG1 IgG3 and IgG4 V0 V4 and V5 although substantial increases were registered for some of these parameters these were not sufficient to describe a definite trend The natural killer NK cell activity did not show significant difference in their functional activity in the treatment group as compared to the placebo group
It has been verified through quality of life questionnaire SF-36 questionnaire that treatment improved Mental Health in the treatment group Nervous Peaceful Happy Down in Dumps Sad compared to the placebo group and clinical significance was found at V4 and V5 General Health and Vitality has been improved at V4 and V5
For each trial participant the adverse eventsserious adverse events occurrences and a brief clinical examination were assessed No special or unusual features of the safety evaluations were found
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