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| Name | Class |
|---|---|
| Laboratoire Cosderma | OTHER |
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The goal of this clinical trial is to test to efficacy of a probiotic blend on stress and skin appearance in young females. It is hypothesized that those taking the probiotic blend will have decreased levels of perceived stress and this will be reflected positively on their skin appearance.
The goal of this open-label clinical trial is to evaluate the potential beneficial effects of a probiotic formulation on mental wellbeing and skin appearance in healthy young adult females in line with the holistic approach context and beauty from within principle. The main questions it aims to answer are related to:
Researchers will compare the outcome assessment measures after the probiotic ingestion to baseline values to highlight any significant effects or trends.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic arm | Experimental | All participants will be given the active probiotic product as this is a single arm, open-label study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | A blend of two probiotic strains. Participants will take 1 capsule daily at 3 billion Colony Forming Units (CFUs) |
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| Measure | Description | Time Frame |
|---|---|---|
| The effect of the probiotic intake on perceived stress levels. | The change from baseline in the level of perceived stress will be assessed by the 10-item perceived stress scale (PSS-10) questionnaire before consumption of the probiotic (baseline) then after 28 and 56 days of intake. The PSS-10 is a widely used self-report questionnaire that measures the degrees to which individuals perceive their lives as unpredictable, uncontrollable, and overloaded. The scale consists of 10 items, which assess the individual's feelings and thoughts related to stress in the past month. The items are designed to capture both positive and negative aspects of stress, including factors such as feeling nervous or stressed, feeling confident in handling personal problems, and feeling that things are going well. The PSS-10 has been extensively used in research studies and clinical settings and has been found to have good reliability and validity. | 56 Days |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of the probiotic intake on sleep quality. | Participants will be asked to complete the 3-item questionnaire adapted from the Canadian Health Measures Survey before consumption of the probiotic (baseline) then after 28 and 56 days of intake. This is not a validated questionnaire; the questions were administered to assess subjective sleep quality among Canadians by Statistics Canada. For each item, the percentage of each answer will be calculated and compared to baseline at Day 28 (mid-intervention) and Day 56 (end of intervention). |
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Inclusion Criteria:
Each participant must fulfill all the inclusion criteria below:
Females between 30 to 45 years old, inclusive.
Caucasian type.
Normal to dry skin to the face (excluded very dry skin).
Have a regular menstrual cycle (participants not known to have hormonal imbalance, be in the pre-menopausal or menopausal state).
Have a skin phototype I, II or III.
Have a negative urine pregnancy test at screening and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months, and participants must agree to sign a release form (Appendix 4).
Other acceptable methods of birth control include:
Able to give free, informed and express consent to participate,
Affiliated with social security in accordance with the recommendations of the French law (Loi Jardé: n° 2016-1537 - 16.11.16) concerning biomedical research.
Visible fine to moderate fine lines on at least one area of the face (e.g., forehead, or crow's feet area, etc.) as assessed by a score ≥ 2 and ≤ 6 on a 10-point clinical scale.
Corneometer® on the face as assessed by an index > 20 and ≤ 60.
Corneometer® on the forearms as assessed by an index ≤ 50.
50% of the participants fulfilling all inclusion criteria and, in addition, self-reported having a sensitive skin.
Does not plan to expose face to sunlight during the study.
Willingness to maintain eating habits for the duration of the study (quick check of diet: sugar/protein/fat/fruit intake and average drink consumption).
Willing to refrain from using any cream and/or makeup on the face, eyes, lips, or palms for study visits and photo capture.
Participants are otherwise healthy and in a good general health and mental health.
Willing to discontinue consumption of probiotic supplements, probiotic fortified products, and fiber supplements for the duration of the study.
Willingness to maintain the same skin care routine for the duration of the study.
Willingness to complete all study visits, assessment questionnaires, and diaries.
Exclusion Criteria:
Eligible participants must not meet any of the non-inclusion criteria below:
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| Name | Affiliation | Role |
|---|---|---|
| Brigitte Milpied | Laboratoire Cosderma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratoire COSDERMA | Bordeaux | 33000 | France |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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A Single Arm, Open-Label, and Proof-of-Concept Study
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| 56 Days |
| The effect of the probiotic intake on skin hydration. | The hydration level of the upper layers of the epidermis will be assessed with the Corneometer CM825® which runs at frequencies between 0.9 and 1.2 MHz. Corneometric index (M) will be reported in units ranging from 5 to 125. The moisturizing effect will be evaluated by comparing measurements taken at baseline and after intervention (at 28 and 56 Days). | 56 Days |
| The effect of the probiotic intake on skin firmness. | Skin firmness will be assessed by Cutometer®. The device generates a negative pressure which can vary between 20 up to 500 mbar. The skin is sucked up inside the probe for 2 seconds with a constant negative pressure.Then the pressure stops, and the skin returns to its initial state. Values obtained at Day 28 and Day 56 twill be compared to baseline. | 56 Days. |
| The effect of the probiotic intake on facial fine lines appearance. | Facial fine lines will be clinically assessed by an experienced technician on a 10-point scale. Assessment will take place on the whole face, forehead, and crow's feet area (0 = no visible fine lines, 9 = very visible fine lines). Assessment will take place at Evalux bench® (Orion concept) with the 3 neon lights (2 lateral and 1 horizontal) turned on. Score recorded at Day 28 and 56 will be compared to baseline. | 56 Days |
| The effect of the probiotic intake on skin tone appearance. | Facial skin tone will be clinically assessed by an experienced technician on a 10-point scale. Assessment will take place on uniformity (0 = Non-uniform complexion, 9 = Very uniform complexion), and radiance (0 = Non-glowy complexion , 9 = Glowy complexion). Assessment will take place at Evalux bench® (Orion concept) with the 3 neon lights (2 lateral and 1 horizontal) turned on, except for the radiance assessment which will take place without the neon lights and only with the light of the room. Score recorded at Day 28 and 56 will be compared to baseline. | 56 Days |
| The effect of the probiotic intake on general skin appearance. | Photographs of the front face and one profile will be taken by Visia-CR® camera. Images will be taken at two settings standard and polarized light. All images will be sent to the Sponsor. No statistical analysis will be performed. Picture will be used for illustrative purpose only. | 56 Days |
| Overall participants' satisfaction with the intervention. | Participants will be asked to complete a self-administered questionnaire designed to assess participant's satisfaction with the product after 28 and 56 days of intake. This questionnaire is written by Cosderma in collaboration with the Sponsor. The answering modalities will be the following: "strongly agree", "somewhat agree", "somewhat disagree", "strongly disagree". A "Non-applicable" option will be added when needed. | 56 Days |
| The effect of the probiotic intake on Gastro-Intestinal (GI) health. | Participants will be asked to complete the 15-item gastrointestinal symptom rating scale (GSRS) questionnaire before starting intervention (baseline) then after 28 and 56 days of intervention. GSRS is a widely used and validated tool. This self-administered questionnaire is designed to assess the frequency and severity of gastrointestinal (GI) symptoms. It consists of 15 items, which are grouped into five subscales:
| 56 Days. |
| The probiotic's safety and tolerability. | Incidence of clinical events (sensations of discomfort or clinical signs) occurring during the study after the consumption of the probiotic. | 56 Days |
| D019602 |
| Food and Beverages |