None listed
Conditions
Brief summary
The primary objective of the study is to evaluate the efficacy of a probiotic to provide benefits to dry and sensitive skin when taken as an oral supplement over 12 weeks. A secondary objective is to determine whether there is a dose dependent effect by comparing 2 doses against a placebo formulation.
Interventions
An oral NZMP™ probiotic supplementation for improvement of skin appearance. Two doses will be used for the probiotics (a high dose of 6 X10^9 CFU and a low dose of 5X10^8 CFU). This will be compared to a placebo. The duration of the study will be 12 weeks. Participants will consume one capsule per day at home. Capsule will be provided at each visit. Participants will be randomly allocated to the High dose group, Low dose group and to the placebo group. At each visit, participants will return th
An oral NZMP™ probiotic supplementation for improvement of skin appearance. Two doses will be used for the probiotics (a high dose of 6 X10^9 CFU and a low dose of 5X10^8 CFU). This will be compared to a placebo. The duration of the study will be 12 weeks. Participants will consume one capsule per day at home. Capsule will be provided at each visit. Participants will be randomly allocated to the High dose group, Low dose group and to the placebo group. At each visit, participants will return the capsule bottles and compliance will be checked.
Sponsors
Fonterra Cooperative Group Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 30 - 65 years. 2. Volunteers who have visible signs of skin dryness and sensitivity, including dry patches, tight rough skin, redness. 3. Volunteers who have completed a sensitive skin questionnaire and achieved the minimum score. 4. Volunteers who are generally healthy with no significant concurrent illnesses or skin disease. 5. Volunteers who have signed the consent form after the nature of the study has been fully explained. 6. Volunteers who are willing to cooperate and participate by following Study requirements. 7. Volunteers who have received a COVID-19 Vaccine and are able to show their vaccine card at consent. 8. Volunteers who have not travelled outside the UK in the last two weeks before starting treatment.
Exclusion criteria
1. Pregnant or breastfeeding or lactating females at the start of the study or have given birth within the previous 6 weeks or are planning to become pregnant during the study. 2. Volunteers who have taken part in a Health Research Authority or MHRA regulated clinical trial (e.g. at a hospital or phase I unit) within the previous eight weeks. Volunteers who have taken part in a study involving the face within the previous four weeks. 3. Volunteers with a recent history (previous 12 months) of significant skin disease requiring medical intervention, e.g. Dermatology outpatient appointment. 4. Volunteers that have a history of skin cancer on the test areas. 5. Volunteers with a recent exposure (previous four weeks) to the sun or sun beds, moderate to pronounced suntan, tattoos, scars or other disfiguration, significant dilated vessels, or other conditions on the test area that, in the opinion of the investigators, might influence the test results. 6. Volunteers with inflammatory acne lesions (i.e., papules, pustules, cysts, nodules) at the test site. 7. Volunteers currently using topically applied prescription medications on/near the test site. 8. Volunteers who have had chemical peels, dermabrasion or facial cosmetic surgery within the last six months. 9. Volunteers currently taking, or have taken within the last 3 months, an oral pro-biotic product. 10. Volunteers currently using topical products, prescription or cosmetic, containing retinoids and derivatives or alpha and beta hydroxy acids 11. Individuals with known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs. 12. Volunteers who have recently made significant dietary changes, including removal of gluten, wheat, dairy or eggs from the diet within the 3 month period prior to study enrolment. 13. Volunteers who currently have symptoms associated with CoVid19 (high temperature, a new continuous cough, loss or change in sense of taste and smell), those who have been advised to self-isolate.
Outcome results
None listed