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Evaluation of the Role of Probiotics on Control and Quality of Life

Evaluation of the Role of Probiotic (Lactovag Vaginal Capsule) on Control, Quality of Life, Anxiety, and Depression in HPV Positive Patients: A Double-Blind Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20101130005280N65
Enrollment
140
Registered
2025-11-14
Start date
2025-11-22
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

HPV. Anal high risk human papillomavirus (HPV) DNA test positive

Interventions

Intervention 1: Intervention group: All participants in this group will receive capsules containing Lactobacillus, manufactured by Zist-Takhmir Company, administered once daily for a duration of six m

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 50 Years

Inclusion criteria

Inclusion criteria: Women aged 30 to 50 years Not menopausal HR.HPV infection criteria include: Positive HR.HPV test (with a new HPV test within the past 6 months) Diagnosis of low-grade squamous intraepithelial lesion (LSIL) by cytology Willing to use an effective method of contraception during the study period Negative pregnancy test within the past 7 days Normal hematology, renal, and liver function tests

Exclusion criteria

Exclusion criteria: History of myocardial infarction, unstable angina, heart failure, or uncontrolled hypertension (=140.90 mmHg) within the past 6 months Systemic treatment for HR.HPV infection within the past 3 months Acute genital infectionPreviously or currently diagnosed malignant tumor Cytological diagnosis of ASC.H, AGC with potential for malignant transformation, or other high-risk lesionsHistological diagnosis of high-grade squamous intraepithelial lesion (HSIL) Documented psychiatric disorders (schizophrenia, psychosis) or uncontrolled epilepsy Significant medical conditions including immunosuppressive disorders (e.g., HIV, rheumatoid arthritis) or current use of immunomodulatory drugs (e.g., immunosuppressive agents) Autoimmune diseases Use of other dietary supplements with imm unomodulatory effects Presence of hepatic, renal, or hematological disease Chronic illnesses, and use of medications that may affect mood (including antidepressants, anti-psychotics, sedatives), alcohol dependence and/or substance abuse any condition that may impair sexual function (including vaginal stenosis, vaginal dryness, active vaginitis, vaginismus, or vaginal atrophy)

Design outcomes

Primary

MeasureTime frame
HPV. Timepoint: At the end of month 6 from the start of the study. Method of measurement: HPV Test.;Quality of life, anxiety and depression. Timepoint: Before and after study. Method of measurement: Beck Anxiety Inventory; Beck Depression Inventory.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZeinab Shaker ardekani

Tehran University of Medical Sciences

Imamhospital@tums.ac.ir+98 21 6658 1625

Outcome results

None listed

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