Skin HealthPhase 1NCT00864188
The Influence of Probiotics in a Drinkable Yogurt on Skin Health
A Phase 1 study testing no bacterial strains, One probiotic strain - Lactobacillus paracasei NCC2461 and Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus in people with Skin Health, run by Société des Produits Nestlé (SPN) at 1 site in Germany.
Trial summary
The aim of this study is to test if probiotics administered to healthy female subjects in a dairy format have any skin health benefits. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- no bacterial strains, One probiotic strain - Lactobacillus paracasei NCC2461 and Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Apr 2010
- Phase
- Phase 1
- 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 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women as assessed by medical history and standard medical examination
- Caucasian
- Age: 25-55 y (inclusive)
- Normal BMI ≤ 30
- Skin type 1-111
- Regular Hormonal Cycle
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- Having given his/her written informed consent
- Willing to avoid the consumption of fermented dairy products
- Minimum consumption of dark chocolate during the period of the study
Who cannot join
- Smoker
- Pregnant or lactating women
- Post menopausal women
- Heavy alcohol intake (usually consuming more than 3 standard drinks/day)
- Intake of chronic medications except oral contraceptive
- Vitamin and/or mineral and/or antioxidant supplementation over the 3 months preceding the initiation of the study and throughout the study.
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- Having skin cancer or genetic disposition to skin cancer
- Regular exposure to artificial UVR
- Daily exposure to sun more than one week over the 2 months preceding the initiation of the study
- Planned vacation to sun during the period of the study.
- Excessive tea drinkers (more than 2 cups a day of green or black tea).
- Excessive consumer of fermented dairy products (more than 150g per day).
- Excessive consumer of dark chocolate (> 25g per day).
- Regular high exercise such as a marathon
- Subject who regularly takes saunas (dry or wet) or swims daily.
- Subject who cannot be expected to comply with treatment
- Currently participating or having participated in another interventional clinical trial during the last 3 months prior to the beginning of this study.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für umweltmedizinische Forschung (IUF) an der Heinrich-Heine-Universität Düsseldorf gGmbH
Düsseldorf, 40225
About this study
Official title: Phase 1 The Influence of Probiotics in a Drinkable Yogurt on Skin Health
The aim of this study is to test if probiotics administered to healthy female subjects in a dairy format have any skin health benefits.
Read the detailed description
This is a placebo-controlled, double blind, randomized, single center, human clinical trial aimed at assessing the influence of probiotics on skin health in healthy female subjects, when administered in a food matrix over a period of 5 months.
It will consist of five groups(40 subjects/group). The first group (1) of subjects will receive acidified milk that does not contain bacterial strains. The second group (2) will receive acidified milk that contains one specific probiotic strain. The third group (3) will receive fermented milk that contains a standard mix of yogurt bacterial strains. The fourth group (4) will receive fermented milk, containing the same standard mix of yogurt bacterial strains as in group 3 plus the same specific probiotic strain as in group 2. Finally, the fifth group (5) will receive fermented milk, containing the same standard mix of yogurt bacterial strains as in group 3 and 4 plus the same specific probiotic strain as in group 2 and 4 plus a mix of antioxidants.
This study will address whether:
A.The bioefficacy of a specific probiotic strain is influenced by a milk matrix.
B.Whether other bacterial strains impact the bioefficacy of this specific probiotic strain, and validate whether or not the bioefficacy is related entirely to the activity of this specific probiotic strain.
C.Whether nutritional supplements impact the bioefficacy of a specific probiotic strain.
- Conditions
- Skin Health
- Being tested
- no bacterial strains, One probiotic strain - Lactobacillus paracasei NCC2461, Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus, Vit B2, B3, C and E, Beta Carotene and Oil
- Keywords
- skin health, probiotics, dairy, oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no bacterial strainsDietary supplement
Glucono-Delta-Lactone acidified milk containing no bacterial strains
One probiotic strain - Lactobacillus paracasei NCC2461Dietary supplement
Glucono-Delta-Lactone acidified or fermented milk containing one probiotic strain.
Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricusDietary supplement
Fermented milk containing two standard yogurt bacterial strains.
Vit B2, B3, C and E, Beta Carotene and OilDietary supplement
Fermented milk containing nutritional supplements
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Glucono-Delta-Lactone acidified milk containing no bacterial strains Receives: Dietary Supplement: no bacterial strains |
| 2 | Experimental | Glucono-Delta-Lactone acidified milk containing one probiotic strain called Lactobacillus paracasei NCC2461. Receives: Dietary Supplement: One probiotic strain - Lactobacillus paracasei NCC2461 |
| 3 | Placebo comparator | Fermented milk containing two standard bacterial strains for acidification - Streptococcus thermophilus and Lactobacillus delbrueckii subsp.bulgaricus. Receives: Dietary Supplement: Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus |
| 4 | Experimental | Fermented milk containing two standard bacterial strains for acidification - Streptococcus thermophilus and Lactobacillus delbrueckii and one probiotic strain called Lactobacillus paracasei NCC2461. Receives: Dietary Supplement: One probiotic strain - Lactobacillus paracasei NCC2461; Dietary Supplement: Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus |
| 5 | Experimental | Fermented milk containing two standard bacterial strains for acidification - Streptococcus thermophilus and Lactobacillus delbrueckii, one probiotic strain called Lactobacillus paracasei NCC2461 and Vitamin B2,B3, C and E, Beta Carotene and an Oil. Receives: Dietary Supplement: One probiotic strain - Lactobacillus paracasei NCC2461; Dietary Supplement: Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus; Dietary Supplement: Vit B2, B3, C and E, Beta Carotene and Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal water loss
Measured: baseline, 1 month, 2 months, 3 months, 5 months and 6 months
Secondary outcomes (1)
Biopsy markers: transglutaminase, filagrin, involucrin, loricrin (mRNA)
Measured: baseline and at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin HealthStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864188
- Sponsor's protocol ID
- 08.29.NRC
- Status last verified
- Sep 2009
- First submitted
- 13 Mar 2009
- Last updated
- 16 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 The Influence of Probiotics in a Drinkable Yogurt on Skin Health
- ClinicalTrials.gov ID
- NCT00864188
- Acronym / sponsor ID
- 08.29.NRC
- Conditions
- Skin Health
- Keywords
- skin health, probiotics, dairy, oral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 18 Mar 2009 (estimated)
- 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 aim of this study is to test if probiotics administered to healthy female subjects in a dairy format have any skin health benefits.
Detailed description
This is a placebo-controlled, double blind, randomized, single center, human clinical trial aimed at assessing the influence of probiotics on skin health in healthy female subjects, when administered in a food matrix over a period of 5 months.
It will consist of five groups(40 subjects/group). The first group (1) of subjects will receive acidified milk that does not contain bacterial strains. The second group (2) will receive acidified milk that contains one specific probiotic strain. The third group (3) will receive fermented milk that contains a standard mix of yogurt bacterial strains. The fourth group (4) will receive fermented milk, containing the same standard mix of yogurt bacterial strains as in group 3 plus the same specific probiotic strain as in group 2. Finally, the fifth group (5) will receive fermented milk, containing the same standard mix of yogurt bacterial strains as in group 3 and 4 plus the same specific probiotic strain as in group 2 and 4 plus a mix of antioxidants.
This study will address whether:
A.The bioefficacy of a specific probiotic strain is influenced by a milk matrix.
B.Whether other bacterial strains impact the bioefficacy of this specific probiotic strain, and validate whether or not the bioefficacy is related entirely to the activity of this specific probiotic strain.
C.Whether nutritional supplements impact the bioefficacy of a specific probiotic strain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: no bacterial strainsGlucono-Delta-Lactone acidified milk containing no bacterial strains |
| 2 | Experimental | Dietary Supplement: One probiotic strain - Lactobacillus paracasei NCC2461Glucono-Delta-Lactone acidified milk containing one probiotic strain called Lactobacillus paracasei NCC2461. |
| 3 | Placebo comparator | Dietary Supplement: Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricusFermented milk containing two standard bacterial strains for acidification - Streptococcus thermophilus and Lactobacillus delbrueckii subsp.bulgaricus. |
| 4 | Experimental | Dietary Supplement: One probiotic strain - Lactobacillus paracasei NCC2461, Dietary Supplement: Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricusFermented milk containing two standard bacterial strains for acidification - Streptococcus thermophilus and Lactobacillus delbrueckii and one probiotic strain called Lactobacillus paracasei NCC2461. |
| 5 | Experimental | Dietary Supplement: One probiotic strain - Lactobacillus paracasei NCC2461, Dietary Supplement: Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus, Dietary Supplement: Vit B2, B3, C and E, Beta Carotene and OilFermented milk containing two standard bacterial strains for acidification - Streptococcus thermophilus and Lactobacillus delbrueckii, one probiotic strain called Lactobacillus paracasei NCC2461 and Vitamin B2,B3, C and E, Beta Carotene and an Oil. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy women as assessed by medical history and standard medical examination
- Caucasian
- Age: 25-55 y (inclusive)
- Normal BMI ≤ 30
- Skin type 1-111
Key exclusion criteria (17 listed)
- Smoker
- Pregnant or lactating women
- Post menopausal women
- Heavy alcohol intake (usually consuming more than 3 standard drinks/day)
- Intake of chronic medications except oral contraceptive
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 |
|---|---|---|
| no bacterial strainsGlucono-Delta-Lactone acidified milk containing no bacterial strains | Dietary supplement | 1 |
| One probiotic strain - Lactobacillus paracasei NCC2461Glucono-Delta-Lactone acidified or fermented milk containing one probiotic strain. | Dietary supplement | 2, 4, 5 |
| Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricusFermented milk containing two standard yogurt bacterial strains. | Dietary supplement | 3, 4, 5 |
| Vit B2, B3, C and E, Beta Carotene and OilFermented milk containing nutritional supplements | Dietary supplement | 5 |
Primary outcome
Transepidermal water loss
Time frame: baseline, 1 month, 2 months, 3 months, 5 months and 6 months
1 secondary outcome
Biopsy markers: transglutaminase, filagrin, involucrin, loricrin (mRNA)
Time frame: baseline and at 5 months
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 16 May 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing no bacterial strains, One probiotic strain - Lactobacillus paracasei NCC2461 and Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus in people with Skin Health, run by Société des Produits Nestlé (SPN) at 1 site in Germany.
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 9 inclusion and 17 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 16 May 2013. 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 Germany. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Transepidermal water loss (time frame: baseline, 1 month, 2 months, 3 months, 5 months and 6 months). 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 16 May 2013.