An interventional study of Oral Lactobacillus reuteri group and Oral administration of inactive Lactobacillus reuteri group in Skin Barrier to Water Loss and Microbial Colonization, sponsored by Shenzhen People's Hospital. Not yet recruiting. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Shenzhen People's Hospital · Not applicable, Interventional, and Treatment
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).
626 studies on the registry are indexed under Communicable Diseases; 128 are open to participants now.
This study's planned enrollment of 140 is above the median of 89 across 380 interventional studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →Shenzhen People's Hospital is the lead sponsor of 63 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Oral administration of inactive Lactobacillus reuteri group
Biological: Oral Lactobacillus reuteri group
1×10\^11 CFU of inactive Lactobacillus reuteri was given orally once daily for one month
1×10\^11 CFU of inactive Lactobacillus reuteri was given orally once daily for one month
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).
Time frame: Baseline, 1 month
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)
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline, 1 month
Change in body weight
Mean change from baseline in total body weight, reported in kilograms (kg).
Time frame: Baseline, 1 month
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Jun 2026, 2 months later.
Of 128 non-industry interventional studies with no phase under Communicable Diseases, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 2 months is below that.
Counting every sponsor, half of 144 studies reached it within 21 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lactobacillus reuteri
Shenzhen People's Hospital