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A Study on the Efficacy and Safety of Oral Probiotic Capsules in Alleviating Vaginitis

A Study on the Efficacy and Safety of Oral Probiotic Capsules in Alleviating Vaginitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123765
Enrollment
Unknown
Registered
2026-04-29
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Vaginitis

Interventions

Experimental Group:To be taken orally once daily, 2 capsules of Bionique female probiotic product each time, for 28 consecutive days.

Sponsors

The First Affiliated Hospital of Anhui University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Having at least one of the following subjective or clinically examined symptoms: - Pruritus of the vulva or vagina. - Burning, pain of the vulva or vagina, or dyspareunia. - Clinically examined congestion and swelling of the vaginal mucosa. 2. Female aged 18-50 years old, with sexual history, non-pregnant and non-lactating. 3. Having signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating females (positive urine pregnancy test before enrollment). 2. Use of antibiotics, antifungal agents or probiotic preparations in the recent 2 weeks prior to enrollment. 3. Use of vaginal contraceptives, cervical caps or other vaginal preparations (e.g., spermicides) in the recent 2 weeks prior to enrollment. 4. Presence of other vaginal infections, such as trichomonal vaginitis, candidiasis (confirmed by wet mount microscopy or culture), gonorrhea or chlamydial infection. 5. Presence of immunodeficiency disorders (e.g., HIV/AIDS), autoimmune diseases, or long-term use of immunosuppressive agents. 6. Hypersensitivity to lactobacilli or any ingredient in the investigational product. 7. Severe hepatic, renal, cardiovascular diseases or psychiatric disorders. 8. Participation in another clinical trial within 30 days. 9. History of vaginal surgery or pelvic radiotherapy. 10. Subjects considered by the investigator to be ineligible for the clinical trial or unable to complete the study for other reasons.

Design outcomes

Primary

MeasureTime frame
Nugent score;Aerobic Vaginitis Score;Lactobacillus percentage;pH value;

Countries

China

Contacts

Public ContactLu Chao

The First Affiliated Hospital of Anhui University of Science and Technology

luchao@aust.edu.cn+86 554 6539 7675

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026