A clinical trial to study the effects of a lactobacilli preparation in bacterial vaginosis, HIV infectivity and vaginal immunity in healthy women and in subjects with bacterial vaginosis

To evaluate the efficacy of a lactobacilli preparation on Bacterial vaginosis, HIV infectivity and vaginal immunity in healthy subjects and subjects with bacterial vaginosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2007/091/000022

Enrollment

140

Registered

2007-12-26

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

None listed

Interventions

Intervention1: Florisia, a proprietary preparation containing three strains of lactobacillus: Each vaginal tablet contains 1 billion viable lactobacilli and is intended for administration into the vag

Eligibility

Inclusion criteria

Inclusion criteria: Healthy women of reproductive age group over 18 years Bacterial vaginosis to be excluded by Nugent score (healthy patients) b.Bacterial vaginosis diagnosis is based on the Nugent method (in patients with bacterial vaginosis) Exclusion of any other vaginal infection by standard diagnostic procedure. Written informed consent

Exclusion criteria

Exclusion criteria: Post menopausal women Pregnant women Abnormal uterine bleeding (not including cervical contact bleeding on sampling) or vaginal bleeding of unknown origin. AIDS patients or patients with any kind of cancer or tumor Diabetes mellitus Drug addiction Antibiotic use (local or systemic) in the previous 20 days. Use of any vaginal medication in the previous 7 days. Participation in any other study 30 days before beginning of the present study. Known or suspected hypersensitivity to any of the ingredients of the trial medication. No informed consent. Patient not willing to comply with the trial instructions.

Design outcomes

Primary

Measure	Time frame
In patients with BV: 1i. Cure – Nugent Score less than 4 and pH less than 4.5 ii. Relapse – BV recurring after a period of remission iii. Failure – Nugent Score ranging from 7 to 10 and pH more than 4.5 2. Susceptibility to BV during the study duration in healthy patients 3. HIV infection inhibition by vaginal secretions from study subjects 4. Vaginal Immunity (TNF-alpha;, IL-1beta; and IL-6)Timepoint: 8 days	—

Measure

Time frame

In patients with BV: 1i. Cure – Nugent Score less than 4 and pH less than 4.5 ii. Relapse – BV recurring after a period of remission iii. Failure – Nugent Score ranging from 7 to 10 and pH more than 4.5 2. Susceptibility to BV during the study duration in healthy patients 3. HIV infection inhibition by vaginal secretions from study subjects 4. Vaginal Immunity (TNF-alpha;, IL-1beta; and IL-6)Timepoint: 8 days

—

Secondary

Measure	Time frame
i. Sphingomyelinase and ceramide concentration in vaginal secretions from study subjects ii. Tolerability of the trial medication Timepoint: 8 days	—

Countries

India

Contacts

Public ContactDr Hemaltha R

National Institute of Nutrition, ICMR

hemalatha_nin@yahoo.co.in09246283362

Outcome results