Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females

NCT06057883 | Completed Phase 2

• 1 other identifier: L-028
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress; Skin Imperfections; Skin Fine Lines

Keywords

Psychobiotic; Probiotics; Perceived Stress; Young Females; Skin; Fine Lines; Hydration; Firmness; Skin Tone; Holistic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• The effect of the probiotic intake on sleep quality.

  56 Days

• The effect of the probiotic intake on skin hydration.

  56 Days

• The effect of the probiotic intake on skin firmness.

  56 Days.

• The effect of the probiotic intake on facial fine lines appearance.

  56 Days

• The effect of the probiotic intake on skin tone appearance.

  56 Days

Study Arms (1)

Probiotic arm

EXPERIMENTAL

All participants will be given the active probiotic product as this is a single arm, open-label study.

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

A blend of two probiotic strains. Participants will take 1 capsule daily at 3 billion Colony Forming Units (CFUs)

Probiotic arm

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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 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.
• Have eyelashes extensions.
• Applied a moisturizing product (hygiene moisturizing product or care product) on the face and forearms within the last 48 hours.

Sponsors & Collaborators

• Lallemand Health Solutions: lead
• Laboratoire Cosderma: collaborator

Study Sites (1)

Laboratoire COSDERMA

Bordeaux, 33000, France

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Brigitte Milpied

  Laboratoire Cosderma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Single Arm, Open-Label, and Proof-of-Concept Study

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 28, 2023
• Study Start: September 27, 2023
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)