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

NCT03307772 | Completed

• 1 other identifier: 08-SBUS-2-GRA-01 A
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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- 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.

Conditions

Herpes Labialis

Keywords

lactobacillus; Herpes Labialis; immune response

Outcome Measures

Primary Outcomes (1)

• Incidence rate of ultraviolet exposure-lesion

  Incidence rate of ultraviolet exposure-lesion at at Day 42.

  Day 42

Secondary Outcomes (14)

• Incidence rate of ultraviolet exposure-lesion

  day 35

• Incidence rate of ultraviolet exposure-lesion

  day 49

• Measurement of lesion size (mm2).

  Day 35 day 42 Day 49

• Time to healing (days).

  Day 35 day 42 Day 49

• Lesion development by classification of lesion stage.

  Day 35 day 42 Day 49

Study Arms (4)

placebo drink

PLACEBO COMPARATOR

The placebo drink consists of fermented low-fat milk with no added Lactobacillus GG.(placebo)

Dietary Supplement: Placebo

LGG Drink (

ACTIVE COMPARATOR

The probiotic drink consists of fermented low-fat milk with added Lactobacillus GG. (probiotics)

Dietary Supplement: Probiotics

FOS Drink

ACTIVE COMPARATOR

The prebiotics drink consists of fermented low-fat milk with fructooligosaccharides. (prebiotics)

Dietary Supplement: Prebiotics

LGG e FOS Drink

ACTIVE COMPARATOR

The probiotics and prebiotics drink consists of acidified low-fat milk with added Lactobacillus GG and fructooligosaccharides (prebiotics and probiotics)

Dietary Supplement: Prebiotics and Probiotics

Interventions

Probiotics DIETARY_SUPPLEMENT

LGG Drink (

Prebiotics DIETARY_SUPPLEMENT

FOS Drink

Prebiotics and Probiotics DIETARY_SUPPLEMENT

LGG e FOS Drink

Placebo DIETARY_SUPPLEMENT

placebo drink

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 herpes labialis at most 3 episodes after exposure to sunlight in the previous 12 months
• Fitzpatrick skin type 1 to 4
• No presence of herpes labialis lesion at the time of recruitment
• Consent to the study and to comply with study product
• Agreement to adhere to the prescribed list of food and nutrients as provided at the start of the study

You may not qualify if:

• Presence of acute/terminal disease
• Intolerance for milk protein or lactose
• Daily consumption of probiotic products 1 month before start of the study
• Treatment with acyclovir or other medication believed to interfere with immune responses at the time of the study
• Participation in any herpes UVB reactivation study within the previous three months
• Episode of herpes labialis within 30 days before enrolment in the study

Sponsors & Collaborators

• Sprim Advanced Life Sciences: lead

MeSH Terms

Conditions

Herpes Labialis

Interventions

Probiotics; Prebiotics

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 12, 2017
• Study Start: December 15, 2008
• Primary Completion: September 16, 2009
• Study Completion: October 20, 2009
• Last Updated: October 12, 2017

Record last verified: 2017-10