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

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 (n=79) and a minidrink containing a combination of a pre- and probiotic (n=78). 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.

Conditions

• Herpes Labialis

Interventions

DIETARY_SUPPLEMENT

Placebo

one bottle of placebo (minidrink fermented with low-fat milk but without Lactobacillus rhamnosus and without FOS, and without viable bacteria 90 grams)per day at breakfast until the end of the study (V5, day 140). At each visit, subjects were dispensed a sufficient amount of minidrinks until the next visit.

DIETARY_SUPPLEMENT

Prebiotics and Probiotics

one bottle of the study product (minidrink with fermented low-fat milk added with Lactobacillus rhamnosus (Lactobacillus rhamnosus) and fructooligosaccharides (FOS),per day at breakfast until the end of the study (V5, day 140). At each visit, subjects were dispensed a sufficient amount of minidrinks until the next visit.

Sponsors & Collaborators

• Sprim Advanced Life Sciences

  lead OTHER

Principal Investigators

• Michelangelo La Placa, master · Dipartimento di Medicina Interna, dell'Invecchiamento e Malattie Nefrologiche Università degli Studi di Bologna

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-09-14

Primary Completion

2011-05-05

Completion

2011-08-01