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Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation

O

Oriflame Cosmetics

Status

Completed

Conditions

Skin Manifestations
Healthy

Treatments

Dietary Supplement: Probiotic without niacin and berry extract
Dietary Supplement: Placebo
Dietary Supplement: Probiotic with niacin and berry extract

Study type

Interventional

Funder types

Industry

Identifiers

NCT05597254
2022-00672-01

Details and patient eligibility

About

The goal of this double-blind randomized clinical trial is to investigate the effects on the skin from oral intake of probiotic supplements in healthy adult men and women. The main questions it aims to answer are: • Will probiotic supplementation result in beneficial changes to different skin parameters? • Will probiotic supplementation result in alterations in the skin microbiome? Participants will consume the study product daily for 8 weeks and come in for skin measurements at baseline and after 8 weeks.

Enrollment

109 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy volunteers
  • Fully informed with the study specifications.
  • Signed consent form prior to commencing the study.
  • Motivated for participation in the study, and available over the full test period.
  • Healthy skin on the face (i.e., absence of psoriasis, eczemas, erythema, oedema, scars, wounds, lesions, or any other type of inflammatory or autoimmune skin condition).
  • Healthy gut (i.e., absence of irritable bowel diseases (IBD), irritable bowel syndrome (IBS), or any other type of inflammatory or autoimmune gut condition).
  • No supplementation with probiotic, prebiotic or synbiotic products 2 weeks prior and/or during the whole study period.
  • No supplementation with niacin (vitamin B3) 2 weeks prior and/or during the whole study period.
  • No significant change in skin care routine (such as injectable cosmetics, skin tanning, etc.) throughout the whole study period.
  • No significant change in the diet throughout the whole study period.

Exclusion criteria

  • Not fulfilling the inclusion criteria.
  • Pregnant or lactating 3 months prior to study commencement or during the study.
  • Women post menopause.
  • Use of antibiotics at least 4 weeks prior and/or during the whole study period.
  • Sun-tanned facial skin.
  • Participating in another clinical study that could interfere with the present research.
  • Presented health problems or specific medications that could adversely affect the study outcome.
  • Presented any cutaneous hypersensitivity or allergy to cosmetic products.
  • Major surgery on the face one year prior to study commencement.
  • Applied any cleansing, topical or moisturizing product (including all make-up products) to the measurement area the morning of assessments at Oriflame Cosmetic AB.
  • Exposure to artificial UV light and/or to the sun during the study.
  • Special diets (vegan, low carbohydrate, weight loss diet, etc.).
  • Significant change in weight one month before or during the study period.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

109 participants in 3 patient groups, including a placebo group

Probiotic with niacin and berry extract
Experimental group
Treatment:
Dietary Supplement: Probiotic with niacin and berry extract
Probiotic without niacin and berry extract
Active Comparator group
Treatment:
Dietary Supplement: Probiotic without niacin and berry extract
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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