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Safety and Efficacy of Lactobacillus reuteri for Androgenetic Alopecia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial

Safety and Efficacy of Lactobacillus reuteri for Androgenetic Alopecia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105724
Enrollment
Unknown
Registered
2025-07-09
Start date
2025-07-10
Completion date
Unknown
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic Alopecia

Interventions

Test Group:Daily application of 1 sachet containing Lactobacillus reuteri powder (˜10? CFU) dissolved in 1 mL normal saline within a brown glass vial. After thorough mixing, 1 mL of the probiotic solu
Inactivated Control Group:Daily application of 1 sachet containing inactivated Lactobacillus reuteri powder (˜10? CFU pre-inactivation) dissolved in 1 mL normal saline within a brown glass vial. After
Positive Control Group:Commercially available 5% minoxidil tincture (Regaine?) was aliquoted into brown glass vials (1 mL/vial). Following daily scalp cleansing, 1 mL solution was topically applied to
Negative Control Group:Normal saline was aliquoted into brown glass vials (1 mL/vial). Following daily scalp cleansing, 1 mL solution was topically applied to the alopecic scalp using cotton swabs. Pa

Sponsors

Shenzhen People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients meeting AGA diagnostic criteria (confirmed by medical history, clinical presentation, and trichoscopy) classified as Norwood-Hamilton stage II-IV or Ludwig grade I-III; 2. Provision of informed consent and voluntary participation; 3. Aged 18-60 years with generally good health status; 4. No use of any hair loss medications within the past six months; 5. Absence of alopecia areata, local infections, or neuromuscular disorders.

Exclusion criteria

Exclusion criteria: 1. AGA progression >5 years; 2. Active skin disease (e.g., psoriasis flare) or uncontrolled diabetes/CVD; 3. Investigator-assessed protocol non-feasibility.

Design outcomes

Primary

MeasureTime frame
Hair Density;

Secondary

MeasureTime frame
Hair Diameter;

Countries

China

Contacts

Public ContactJianglin Zhang

Shenzhen People’s Hospital (The First Affiliated Hospital, Southern University of Science and Techno )

zhang.jianglin@szhospital.com+86 138 7314 3466

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026