Two Supplemented Against Skin Reactivity
Condition: Skin Sensitivity; Trans-epidermal Water Loss; Clinical Score; Assessment of Skin Moisturization Factors; Assessment of Serum Immune-regulatory Cytokine; Evaluation of Intestinal Flora Composition
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      The probiotics and particularly Lactobacillus paracasei and Bifidobacterium longum are of
      value with respect to the homeostasis of dry and sensitive skin.

      An initial study (study report No. 1020813, DERMSCAN dated 2/10/2004) showed that the
      combination of L. paracasei NCC2461 (ST11) with Bifidobacterium lactis NCC2818 (Bb12) induced
      an improvement in certain parameters related to skin reactivity. However, the probiotics have
      not been tested separately.

      It was thus considered important to conduct a clinical trial aiming at confirming and
      documenting the data generated by the previous study and, also determining the specific
      efficacy of L. paracasei NCC2461 (ST11) on reactive skin symptoms. The latter probiotic
      strain was selected on the basis of its proven immune-modulatory properties (scientific
      dossier ST11-Nestec Benyacoub and Gueniche. Scientific evidence supporting the use of
      Lactobacillus paracasei NCC2461 (ST11) for Innéov. Report 11.02.2005 and references 23, 24,
      31-33). The strain was combined or not with a probiotic of the Bifidobacterium genus,
      particularly Bifidobacterium longum NCC3001. The data generated by various preclinical
      studies (NRC in-house studies) and clinical studies (public) show that this probiotic strain
      is able to modulate immune mechanisms and could interfere with inflammatory reactions.

      Moreover, the probiotic combination concept enables providing potential benefit all along the
      gastrointestinal tract, inducing maintenance of an optimum intestinal flora.
    

Intervention name(s): Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Skin sensitivity; Trans-epidermal water loss; Clinical score; skin moisturization factors; serum immune-regulatory cytokine; Evaluation of intestinal flora composition