Skin Barrier to Water LossNCT07512050
Oral Lactobacillus Reuteri for Skin Barrier Dysfunction in Obesity
A study testing Oral Lactobacillus reuteri group and Oral administration of inactive Lactobacillus reuteri group in people with Skin Barrier to Water Loss and Microbial Colonization, run by Shenzhen People's Hospital.
Trial summary
This clinical trial aims to evaluate the safety and efficacy of oral Lactobacillus reuteri supplementation for treating obesity-induced skin barrier impairment in individuals aged 18-40 with a BMI ≥30. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Barrier to Water Loss, Microbial Colonization
- What is being tested?
- Oral Lactobacillus reuteri group and Oral administration of inactive Lactobacillus reuteri group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Meets 2020 WHO BMI classification:
- a. Normal weight (18.5-24.9 kg/m²)
- b. Overweight (25-29.9 kg/m²)
- c. Obesity (≥30 kg/m²)
- 2. Presence of skin barrier impairment (e.g., dryness, erythema, desquamation, or itching)
- 3. Age 18-40 years
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- 4. Generally good health (no active systemic diseases)
- 5. Able and willing to provide written informed consent
- 6. No use of oral/topical medications or probiotics within 6 months prior
- 7. No active skin disease or traumatic skin lesions
Who cannot join
- 1. Known allergy or hypersensitivity to probiotics, placebo, or investigational product
- 2. Active skin disease (e.g., psoriasis, eczema, infection) requiring treatment
- 3. Severe medical conditions:
- a. Cardiopulmonary disease (NYHA class III/IV)
- b. Uncontrolled diabetes (HbA1c >9%)
- c. Autoimmune disorders
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- 4. Pregnant or breastfeeding women
- 5. Any condition that may interfere with protocol compliance (per investigator judgement), including:
- a. Inability to understand study procedures
- b. History of poor clinical trial adherence
- 6. Concurrent participation in other interventional trials
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Changzhou Li contact
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Oral Lactobacillus Reuteri in Treating Skin Barrier Function Impairment Caused by Obesity.
This clinical trial aims to evaluate the safety and efficacy of oral Lactobacillus reuteri supplementation for treating obesity-induced skin barrier impairment in individuals aged 18-40 with a BMI ≥30. The study focuses on the following questions:
Can oral Lactobacillus reuteri supplementation reduce skin barrier damage (measured by transepidermal water loss/TEWL) in obese participants? Does modulation of gut microbiota with Lactobacillus reuteri impact skin barrier function and systemic inflammation?
Read more
Researchers will compare outcomes across two groups:
Intervention Group (Obese): Oral Lactobacillus reuteri capsules. Placebo Control Group (Obese): Oral inactive (heat-killed) Lactobacillus reuteri.
Participant Procedures:
Take daily oral capsules (Lactobacillus reuteri or inactive strain) for 4 weeks.
Undergo non-invasive skin testing (TEWL measurements) at baseline and study completion.
Provide stool and samples for analyses. Complete weekly check-ins to report adverse effects (e.g., gastrointestinal discomfort, skin irritation).
- Conditions
- Skin Barrier to Water Loss, Microbial Colonization
- Being tested
- Oral Lactobacillus reuteri group, Oral administration of inactive Lactobacillus reuteri group
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Lactobacillus reuteri groupBiological
1×10^11 CFU of inactive Lactobacillus reuteri was given orally once daily for one month
Oral administration of inactive Lactobacillus reuteri groupBiological
1×10^11 CFU of inactive Lactobacillus reuteri was given orally once daily for one month
| Study group | Role | What they receive |
|---|---|---|
| Oral administration of inactive Lactobacillus reuteri group | Sham comparator | Not described Receives: Biological: Oral administration of inactive Lactobacillus reuteri group |
| Oral Lactobacillus reuteri group | Experimental | Not described Receives: Biological: Oral Lactobacillus reuteri group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Transepidermal Water Loss (TEWL)
Mean change from baseline in transepidermal water loss (TEWL) on the volar forearm, measured by Tewameter under standardized conditions, reported in grams per square meter per hour (g/m²/h).
Measured: Baseline, 1 month
Secondary outcomes (5)
Change in Fecal Genistein Concentration
Mean change from baseline in the concentration of genistein in fecal samples, quantified using LC-MS/MS, reported in micrograms per gram (μg/g)
Measured: Baseline, 1 month
Change in Skin Microbial Alpha Diversity
Mean change from baseline in the Shannon Diversity Index of skin microbiota, assessed via 16S rRNA gene sequencing.
Measured: Baseline, 1 month
Change in clinical skin health score
Mean change from baseline in the total score of the Skin Dryness Scoring System, reported as a continuous score (0-8, replace with your scale range).
Measured: Baseline, 1 month
Change in Body Mass Index (BMI)
Mean change from baseline in Body Mass Index (BMI), calculated as weight in kilograms divided by height in meters squared, reported in kg/m².
Measured: Baseline, 1 month
Change in body weight
Mean change from baseline in total body weight, reported in kilograms (kg).
Measured: Baseline, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion28 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Barrier to Water LossStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512050
- Sponsor's protocol ID
- LL-KY-2025272-02
- Status last verified
- Nov 2025
- First submitted
- 3 Dec 2025
- Last updated
- 6 Apr 2026
- Results posted
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Oral Lactobacillus Reuteri in Treating Skin Barrier Function Impairment Caused by Obesity.
- ClinicalTrials.gov ID
- NCT07512050
- Acronym / sponsor ID
- LL-KY-2025272-02
- Conditions
- Skin Barrier to Water Loss, Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 28 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 6 Apr 2026 (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.
This clinical trial aims to evaluate the safety and efficacy of oral Lactobacillus reuteri supplementation for treating obesity-induced skin barrier impairment in individuals aged 18-40 with a BMI ≥30. The study focuses on the following questions:
Can oral Lactobacillus reuteri supplementation reduce skin barrier damage (measured by transepidermal water loss/TEWL) in obese participants? Does modulation of gut microbiota with Lactobacillus reuteri impact skin barrier function and systemic inflammation?
Researchers will compare outcomes across two groups:
Intervention Group (Obese): Oral Lactobacillus reuteri capsules. Placebo Control Group (Obese): Oral inactive (heat-killed) Lactobacillus reuteri.
Participant Procedures:
Take daily oral capsules (Lactobacillus reuteri or inactive strain) for 4 weeks.
Undergo non-invasive skin testing (TEWL measurements) at baseline and study completion.
Provide stool and samples for analyses. Complete weekly check-ins to report adverse effects (e.g., gastrointestinal discomfort, skin irritation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral administration of inactive Lactobacillus reuteri group | Sham comparator | Biological: Oral administration of inactive Lactobacillus reuteri group |
| Oral Lactobacillus reuteri group | Experimental | Biological: Oral Lactobacillus reuteri group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 1. Meets 2020 WHO BMI classification:
- a. Normal weight (18.5-24.9 kg/m²)
- b. Overweight (25-29.9 kg/m²)
- c. Obesity (≥30 kg/m²)
- 2. Presence of skin barrier impairment (e.g., dryness, erythema, desquamation, or itching)
Key exclusion criteria (11 listed)
- 1. Known allergy or hypersensitivity to probiotics, placebo, or investigational product
- 2. Active skin disease (e.g., psoriasis, eczema, infection) requiring treatment
- 3. Severe medical conditions:
- a. Cardiopulmonary disease (NYHA class III/IV)
- b. Uncontrolled diabetes (HbA1c >9%)
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 |
|---|---|---|
| Oral Lactobacillus reuteri group1×10^11 CFU of inactive Lactobacillus reuteri was given orally once daily for one month | Biological | Oral Lactobacillus reuteri group |
| Oral administration of inactive Lactobacillus reuteri group1×10^11 CFU of inactive Lactobacillus reuteri was given orally once daily for one month | Biological | Oral administration of inactive Lactobacillus reuteri group |
Primary outcome
Change in Transepidermal Water Loss (TEWL)
Time frame: Baseline, 1 month
Mean change from baseline in transepidermal water loss (TEWL) on the volar forearm, measured by Tewameter under standardized conditions, reported in grams per square meter per hour (g/m²/h).
5 secondary outcomes
Change in Fecal Genistein Concentration
Time frame: Baseline, 1 month
Change in Skin Microbial Alpha Diversity
Time frame: Baseline, 1 month
Change in clinical skin health score
Time frame: Baseline, 1 month
Change in Body Mass Index (BMI)
Time frame: Baseline, 1 month
Change in body weight
Time frame: Baseline, 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- 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.
Changzhou Li contact
Questions about this trial
What is this clinical trial studying?
A study testing Oral Lactobacillus reuteri group and Oral administration of inactive Lactobacillus reuteri group in people with Skin Barrier to Water Loss and Microbial Colonization, run by Shenzhen People's Hospital.
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 10 inclusion and 11 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: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianglin Zhang (+86 13873143466, zhang.jianglin@szhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Transepidermal Water Loss (TEWL) (time frame: Baseline, 1 month). 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 6 Apr 2026.