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: * Probiotics effects on stress. * Probiotics effects on sleep quality. * Probiotics effects on skin appearance (fine lines and skin tone) and parameters (hydration and firmness) Participants will be recruited and, if consenting and eligible, will be provided with the probiotic capsules and instructed to ingest one capsule daily, preferably in the evening for 56 consecutive days. In-person visits will take place at baseline, mid-intervention (Day 28), and end of intervention (Day 56) to carry out assessment activities at Cosderma site. Researchers will compare the outcome assessment measures after the probiotic ingestion to baseline values to highlight any significant effects or trends.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
35
A blend of two probiotic strains. Participants will take 1 capsule daily at 3 billion Colony Forming Units (CFUs)
Laboratoire COSDERMA
Bordeaux, France
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.
Time frame: 56 Days
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).
Time frame: 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).
Time frame: 56 Days
The effect of the probiotic intake on skin firmness.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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: 1. Abdominal pain 2. Reflux syndrome 3. Indigestion syndrome 4. Diarrhea syndrome 5. Constipation syndrome Average total scores at Day 28 (mid-intervention) and Day 56 (end of intervention) will be compared to baseline.
Time frame: 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.
Time frame: 56 Days