StressPhase 2CosmebiomeNCT06057883
Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females
A Phase 2 study testing Probiotic in people with Stress and Skin Imperfections, run by Lallemand Health Solutions at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Skin Imperfections, Skin Fine Lines
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 27 Sep 2023to 24 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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:
- Abstinence or agrees to use contraception if planning to become sexually active
- Hormonal contraceptives
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle
- Vasectomy of partner at least 6 months prior to screening
- 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.
Who cannot join
- Eligible participants must not meet any of the non-inclusion criteria below:
- Currently pregnant, or breast feeding, or planning to be pregnant during the study.
- Current smoker.
- Suffering from a chronic or acute skin condition on the face and forearms (atopic dermatitis, acne, eczema, psoriasis, rash, severe dryness, etc.), unless the condition is deemed stabilized and will not affect study outcomes or be negatively affected by the intervention in the opinion of the investigator.
- Current use of antiaging products, unless the participant has been using the same product, with the same frequency and concentration for the past ≥ 3 months.
- Introduction of a new antiaging product during the study, or a change in the frequency or concentration of a routinely used antiaging product.
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- Introduction of new skin care products during the study, unless medically prescribed.
- Facial surgery 5 years before study start.
- Chemical treatment (e.g., Botox injection) within 1 year before study start.
- Frequent UV exposure or expect high exposure to the sun during the study.
- Diagnosed with a general physical or mental health problem (e.g., diabetes, peptic ulcer, inflammatory bowel disease, depression, anxiety, insomnia, etc.) or systemic disease that may pose a safety risk, interfere with the dietary intake of the investigational product, or impact the assessment of study outcomes.
- Diagnosed with an autoimmune disease or are immune compromised due to medical condition or medications intake (e.g., acquired immunodeficiency (HIV), organ transplant, lymphoma, chemotherapy, chronic corticosteroids intake, etc.).
- Currently taking oral or local anti-inflammatory treatment or have been taken daily anti-inflammatory therapy in the 2 weeks preceding the inclusion visit. Note: participants could be eligible to participate after a 2-week washout period.
- Currently on corticosteroid treatment or antihistamines or other dermatological treatment or specialties based on vitamin A acid or its derivatives in the 2 weeks preceding the study. Note: participants could be eligible to participate after a 2-week washout period.
- Treated with an oral retinoid within 6 months prior to the study.
- Subjects who have applied make-up products to the face and forearms the day of the inclusion visit.
- Subjects who have washed their face and forearms with any other means than clear water (no soap or cleanser) on the day of the inclusion visit.
- Applied self-tanning products to the face and forearms within 2 weeks preceding the inclusion visit. Note: participants could be eligible to participate after a 2-week washout period.
- Have eyelashes extensions.
- Applied a moisturizing product (hygiene moisturizing product or care product) on the face and forearms within the last 48 hours.
- Wearing tight clothing that do not let the forearms show.
- Performed hair removal on the forearms within the last 48 hours.
- Have cutaneous marks on the face and forearms which could interfere with the skin's clinical signs assessment (pigmentation issues, scar tissues, over-developed hairiness, too many ephelides and naevi, sunburns, tattoos, etc.).
- Currently using a supplement that could affect study outcomes such as melatonin.
- Use of probiotics other than the study supplement within 1 month of the inclusion visit. Note: participants could be eligible to participate after a 4-week washout period.
- Use of any antibiotic drug within 1 month of the inclusion visit. Note: participants could be eligible to participate after a 4-week washout period.
- Subjects working as staff at Cosderma.
- Intending to be vaccinated during the study period.
- Currently enrolled or intending to be enrolled in another trial during the study period, or not meeting their 2 weeks exclusion period since their last participation in a study.
- Subjects who have been deprived of their liberty by administrative or legal decision or under judicial supervision.
- Subjects who could not be contacted in an emergency by phone.
- Milk or soy allergy or severe lactose intolerance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Probiotics Formulation on Stress and Skin Health in Younger Adult Females: A Holistic Approach to Skin Health, an Open-Label Proof-of-Concept Study
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.
Read the detailed description
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.
- Conditions
- Stress, Skin Imperfections, Skin Fine Lines
- Being tested
- Probiotic
- Keywords
- Psychobiotic, Probiotics, Perceived Stress, Young Females, Skin, Fine Lines, Hydration, Firmness, Skin Tone, Holistic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
A blend of two probiotic strains. Participants will take 1 capsule daily at 3 billion Colony Forming Units (CFUs)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic arm | Experimental | All participants will be given the active probiotic product as this is a single arm, open-label study. Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 56 Days
Secondary outcomes (9)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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:
- Abdominal pain
- Reflux syndrome
- Indigestion syndrome
- Diarrhea syndrome
- Constipation syndrome Average total scores at Day 28 (mid-intervention) and Day 56 (end of intervention) will be compared to baseline.
Measured: 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.
Measured: 56 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start27 Sep 2023
- Primary completion24 Nov 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Single Arm, Open-Label, and Proof-of-Concept Study
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lallemand Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratoire Cosderma
- Responsible party
- Sponsor
- Investigators
- Brigitte Milpied, Principal investigator, Laboratoire Cosderma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057883
- Sponsor's protocol ID
- L-028
- Acronym
- Cosmebiome
- Status last verified
- Feb 2024
- First submitted
- 19 Sep 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics Formulation on Stress and Skin Health in Younger Adult Females: A Holistic Approach to Skin Health, an Open-Label Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT06057883
- Acronym / sponsor ID
- Cosmebiome / L-028
- Conditions
- Stress, Skin Imperfections, Skin Fine Lines
- Keywords
- Psychobiotic, Probiotics, Perceived Stress, Young Females, Skin, Fine Lines, Hydration, Firmness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Lallemand Health SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Laboratoire Cosderma
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Single Arm, Open-Label, and Proof-of-Concept Study
| Arm | Type | Receives |
|---|---|---|
| Probiotic arm | Experimental | Dietary Supplement: ProbioticAll participants will be given the active probiotic product as this is a single arm, open-label study. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (27 listed)
- 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.
Key exclusion criteria (32 listed)
- Currently pregnant, or breast feeding, or planning to be pregnant during the study.
- Current smoker.
- Suffering from a chronic or acute skin condition on the face and forearms (atopic dermatitis, acne, eczema, psoriasis, rash, severe dryness, etc.), unless the condition is deemed stabilized and will not affect study outcomes or be negatively affected by the intervention in the opinion of the investigator.
- Current use of antiaging products, unless the participant has been using the same product, with the same frequency and concentration for the past ≥ 3 months.
- Introduction of a new antiaging product during the study, or a change in the frequency or concentration of a routinely used antiaging product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticA blend of two probiotic strains. Participants will take 1 capsule daily at 3 billion Colony Forming Units (CFUs) | Dietary supplement | Probiotic arm |
Primary outcome
The effect of the probiotic intake on perceived stress levels.
Time frame: 56 Days
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.
9 secondary outcomes
The effect of the probiotic intake on sleep quality.
Time frame: 56 Days
The effect of the probiotic intake on skin hydration.
Time frame: 56 Days
The effect of the probiotic intake on skin firmness.
Time frame: 56 Days.
The effect of the probiotic intake on facial fine lines appearance.
Time frame: 56 Days
The effect of the probiotic intake on skin tone appearance.
Time frame: 56 Days
The effect of the probiotic intake on general skin appearance.
Time frame: 56 Days
Overall participants' satisfaction with the intervention.
Time frame: 56 Days
The effect of the probiotic intake on Gastro-Intestinal (GI) health.
Time frame: 56 Days.
The probiotic's safety and tolerability.
Time frame: 56 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Milpied principal investigator
Laboratoire Cosderma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Stress and Skin Imperfections, run by Lallemand Health Solutions at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of the probiotic intake on perceived stress levels. (time frame: 56 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.