Clinical Trial: Microbiological Impact of an Intimate Cream and Its Suitability to Contribute to the Feeling of Softness and Freshness in the Intimate Area of Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Microbiological Impact of a Cream and the Feeling of Softness and Freshness in the Intimate Area of Women

Brief Summary:

Generate more information on the use of the Probiotic Intimate Crème regarding feeling of dryness and freshness in the intimate area, as well as to evaluate the Lactobacillus flora and presence of coliform bacteria in respect to E. coli in the intimate area of women before use of the crème and at the end of a 10 days crème-usage (day 8-10), as well as 10 days after (9-11 days) finished crème-usage.

The hypothesis is that lactobacilli can survive in the intimate area of postmenopausal women with use of a probiotic creme.


Detailed Summary:

The rational for using probiotics is that the humans are colonized by a numbers of microorganisms from birth. These microorganisms are the natural flora of the human body. This bacterial ecology may be imbalanced due different circumstances: excessive hygiene, use of antibiotics or other drugs, use of alcohol, smoking, stress, diabetes and many other factors. The natural bacterial flora in the external part of the genital tract might be promoted by help of intimate products containing probiotics.

The study objectives Generate more information on the use of the Probiotic Intimate Crème regarding feeling of dryness and freshness in the intimate area, as well as to evaluate the Lactobacillus flora and presence of coliform bacteria in respect to E. coli in the intimate area of women before and at the end of a 10 days crème-usage (day 8-10), as well as 10 (9-11) days after finished crème-usage.

The primary endpoint of the study Presence of at least one LN bacteria strain in the intimate area of women in the intervention group compared to the intimate area of women in the control group at the end of a 10 days crème-usage (Day 8-10), as well as 10 (9-11) days after finished crème-usage. The primary endpint will be measured by bacterial Culture.

None-parametric statistical analyses.

Secondary endpoints Obtain information about the coliform bacteria flora in respect to E. coli flora in the external intimate area before and at the end of the 10 days crème-usage (Day 8-10), as well as 10 days after finished crème-usage (9-11 days after).

Obtain information about the subjective feeling of dryness and freshness in the intimate of women before and at the
Sponsor: Karolinska Institutet

Current Primary Outcome: Presence of at least one LN bacteria strain in the intimate area of women in the intervention group [ Time Frame: the end of a 10 days crème-usage ]

Bacterial Culture of LN bacterial strains


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Obtain information about the coliform bacteria flora in respect to E. coli flora in the external intimate area [ Time Frame: at the end of creme usage and 10 days after finished crème-usage (9-11 days after). ]
    Measured by bacterial Culture and subtyping by PCR
  • subjective feeling of dryness and freshness in the intimate of women [ Time Frame: the end of the 10 days crème-usage (Day 8-10) and 10 days after finished crème-usage (9-11 days after) ]
    Assessed through self adminstered questionnair with grading of feeling of dryness and freshness on a scale from 0 (no dryness and feeling fresh) to 5 (max dryness and absolutely not feeling fresh)


Original Secondary Outcome: Same as current

Information By: Karolinska Institutet

Dates:
Date Received: November 21, 2013
Date Started: September 2013
Date Completion:
Last Updated: November 25, 2015
Last Verified: November 2015