Two Supplemented Against Skin Reactivity

Summary

In recent decades, the incidence of subjects presenting reactive skin has considerably increased in industrialized countries. Probiotics are live microorganisms which, when ingested in sufficient amounts, have beneficial effects on human health. The mechanism underlying the effect of probiotics involves, in part, regulation of the composition and/or metabolic activity of the intestinal microbiota.. It is postulated that following interaction of probiotics with the intestinal epithelium, associated intestinal cells become activated and consequently mediators are released into the blood circulation. Mediators, activated intestinal epithelial cells and possibly bacterial fractions might reach the skin through the bloodstream where they potentially could exert effects.The objective of this study was to assess the effects of probiotics on reactive skin symptoms. The strain Lactobacillus paracasei NCC2461 was tested alone and in combination with the strain Bifidobacterium longum NCC3001 in a randomized, double-blind study. The two strains were selected for their immune-modulatory properties demonstrated in in vitro and other preclinical studies as well as in a pilot clinical trial.

Ninety-six women presenting reactive skin were randomized to 3 groups: placebo (n = 32), L. paracasei NCC2461 alone (n = 32) and L. paracasei NCC2461 + B. longum NCC3001 (n = 32). The supplements were administered by the oral route for 58 days (1010 CFU/day).

The objective of the clinical trial was to determine, in vivo, the effect of food supplements on reactive skin symptoms (as measured by skin sensitivity and the reconstruction of barrier function post-repeated tape stripping).

The secondary objectives were to determine the effect of the food supplements on leg skin dryness and facial skin roughness and the associated biochemical, immunological and microbiological factors.

Accordingly, the subjects' skin sensitivity was determined by the capsaicin test. The reconstruction of barrier function was determined by measuring the trans-epidermal water loss (TEWL) post-repeated stripping using a SERVOMED evaporimeter. A clinical score for skin dryness and roughness was assigned by a dermatologist. The subjects also assessed their leg and facial skin dryness themselves. Each analysis was conducted at the various time points.

In parallel, assessment of the skin moisturizing factors and serum inflammatory and immune-regulatory cytokines were performed. Finally, key components of the intestinal microbiota were analyzed.

Conditions

• Skin Sensitivity
• Trans-epidermal Water Loss
• Clinical Score
• Assessment of Skin Moisturization Factors
• Assessment of Serum Immune-regulatory Cytokine
• Evaluation of Intestinal Flora Composition

Interventions

DIETARY_SUPPLEMENT

Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001

1 treatment unit, in the form of a sachet of powder, to be reconstituted in a glass of water and taken once daily for 8 weeks (from D1 to D57), except if the last visit is bring forward or put back for no more than 3 days, in which case the subject will continue treatment until the final visit. Oral route.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN)

  collaborator INDUSTRY

• L'Oreal

  lead INDUSTRY

Principal Investigators

• Frédéric BOUDJEMA, MD · Dermscan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2004-06-30

Primary Completion

2006-03-31

Completion

2006-03-31

Countries

• France

Study Locations