Institut für umweltmedizinische Forschung (IUF) an der Heinrich-Heine-Universität Düsseldorf gGmbH
Düsseldorf, 40225, Germany
NCT Number: NCT00864188
The aim of this study is to test if probiotics administered to healthy female subjects in a dairy format have any skin health benefits.
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Notify Me25 year–55 year
Female
Interventional
Phase 1
Düsseldorf, 40225, Germany
This is a placebo-controlled, double blind, randomized, single center, human clinical trial aimed at assessing the influence of probiotics on skin health in healthy female subjects, when administered in a food matrix over a period of 5 months.
It will consist of five groups(40 subjects/group). The first group (1) of subjects will receive acidified milk that does not contain bacterial strains. The second group (2) will receive acidified milk that contains one specific probiotic strain. The third group (3) will receive fermented milk that contains a standard mix of yogurt bacterial strains. The fourth group (4) will receive fermented milk, containing the same standard mix of yogurt bacterial strains as in group 3 plus the same specific probiotic strain as in group 2. Finally, the fifth group (5) will receive fermented milk, containing the same standard mix of yogurt bacterial strains as in group 3 and 4 plus the same specific probiotic strain as in group 2 and 4 plus a mix of antioxidants.
This study will address whether:
A.The bioefficacy of a specific probiotic strain is influenced by a milk matrix.
B.Whether other bacterial strains impact the bioefficacy of this specific probiotic strain, and validate whether or not the bioefficacy is related entirely to the activity of this specific probiotic strain.
C.Whether nutritional supplements impact the bioefficacy of a specific probiotic strain.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Glucono-Delta-Lactone acidified milk containing no bacterial strains
Glucono-Delta-Lactone acidified or fermented milk containing one probiotic strain.
Fermented milk containing two standard yogurt bacterial strains.
Fermented milk containing nutritional supplements
Time frame: baseline, 1 month, 2 months, 3 months, 5 months and 6 months
Time frame: baseline and at 5 months
Société des Produits Nestlé (SPN)
Industry
Phase 1 The Influence of Probiotics in a Drinkable Yogurt on Skin Health
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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