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

NCT03310294 | Completed

• 1 other identifier: 10-CLI-GRA-02
• Study Type: interventional
• Target: 157
• Locations: 0 countries
• Sites: N/A

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 (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

Keywords

Lactobacillus; Herpes Labial; Immune repsonse

Outcome Measures

Primary Outcomes (1)

• reduction of HL recurrence.

  to evaluate the coadjuvant effect of the combination of prebiotic and probiotic mix in the reduction of the number of HL recurrences at day 49 vs baseline.

  Day 49

Secondary Outcomes (14)

• reduction of HL recurrence.

  day 14

• reduction of HL recurrence.

  day 140

• change IGS markers concentration

  day 14

• change IGS markers concentration

  day 49

• change IGS markers concentration

  day 140

Study Arms (2)

placebo

PLACEBO COMPARATOR

one bottle of placebo (minidrink fermented with low-fat milk but without Lactobacillus rhamnosus and without FOS, and without viable bacteria 90 grams)

Dietary Supplement: Placebo

Prebiotics and Probiotics

ACTIVE COMPARATOR

one bottle of the study product (minidrink with fermented low-fat milk added with Lactobacillus rhamnosus (Lactobacillus rhamnosus) and fructooligosaccharides (FOS), 90 grams)

Dietary Supplement: Prebiotics and Probiotics

Interventions

Placebo DIETARY_SUPPLEMENT

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.

placebo

Prebiotics and Probiotics DIETARY_SUPPLEMENT

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.

Prebiotics and Probiotics

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy free-living men and women aged 18 to 65 years-old.
• History of recurrent HL (2 - 4 episodes) after exposure to sunlight in the previous 12 months.
• Fitzpatrick skin type 1 to 4 (appendix 1 of the study protocol).
• No presence of HL lesions at time of recruitment, including baseline.
• Agreement to adhere to the prescribed list of dietary recommendations provided at the start of the study (appendix 3 of the study protocol).
• Women of child-bearing potential are required to use adequate birth protection during the study.
• Sign and date the ICF to and to comply with study procedures

You may not qualify if:

• Presence of acute/terminal disease.
• Intolerance for milk protein or lactose.
• Treatment with acyclovir or other medication believed to interfere with immune responses at the time of the study.
• Participation in any herpes UV reactivation study within the previous three months.
• Pregnancy or lactation.
• Any condition (e.g. schizophrenia, psychosis, major depression or mental deficiency) or major co-morbidity that the study investigator thinks might compromise the person's ability to comply with the requirements of the study.

Sponsors & Collaborators

• Sprim Advanced Life Sciences: lead

MeSH Terms

Conditions

Herpes Labialis

Interventions

Prebiotics; Probiotics

Condition Hierarchy (Ancestors)

Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Michelangelo La Placa, master

  Dipartimento di Medicina Interna, dell'Invecchiamento e Malattie Nefrologiche Università degli Studi di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: As a double blind study neither the researchers nor the participants knew which treatment each participant received. The treatment was randomly allocated to the subjects according to the procedure for treatment assignment described above. To maintain the blind (see also paragraph 4.4.1) no differences between the active treatment and the placebo were evident on the package, and the carton boxes containing the study products were identified by a number corresponding to the randomization (the products will be labelled with a batch number, Investigator/center, subject ID number and expiry date).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase IV, parallel, placebo-controlled, double-blind, multicenter, randomized study to evaluate the effect of a combination of probiotics and prebiotics in subjects with recurrent Herpes labialis. This specific design has been chosen as the most suitable to achieve the objectives of the trial, mainly the demonstration of the clinical efficacy of the combination of probiotics and prebiotics in subjects with recurrent Herpes labialis in terms of reduction of the number of HL recurrences at day 49 vs baseline.

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 16, 2017
• Study Start: September 14, 2010
• Primary Completion: May 5, 2011
• Study Completion: August 1, 2011
• Last Updated: October 16, 2017

Record last verified: 2017-10