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Probiotics to reduce the incidence of recurrent urinary tract infections

Randomized, placebo controlled trial of administering oral and vaginal probiotics (VSL#3 and Florisia) in reducing the incidence of recurrent UTI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/02/004425
Enrollment
176
Registered
2014-02-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: Z874- Personal history of diseases of genitourinary system

Interventions

Intervention1: VSL#3 capsule: Each VSL#3 capsule contains not less than 112.5 billion colony forming units of 8 strains of lactic acid bacteria and bifidobacteria. The drug will be given orally 2 caps

Sponsors

Indian Council of Medical Research
Lead Sponsor
Next Gen Pharma India Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pre-menopausal women aged 18-45 years 2. History of three or more uncomplicated UTIs diagnosed in the past year, or two uncomplicated UTIs diagnosed in the past six months 3. Sterile urine culture at baseline 4. Agree for completion of screening procedures and agree to return for the subsequent follow up visits 5. Willing to insert vaginal tablet without an applicator 6. Capable of providing informed consent 7. Agree to abstain from self-medication with antibiotics for the UTI symptoms 8. Agree to abstain from antibiotic prophylaxis for recurrent UTI 9. Agree to abstain from the use of any other intra-vaginal product 10. Agree to abstain from sexual intercourse during 8 days course of vaginal tablet

Exclusion criteria

Exclusion criteria: 1. All pregnant and lactating females 2. Those suffering from any disease of upper or lower urinary tract including pyelonephritis and UTI due to drug resistant strain 3. Patient with history of relapse of UTI within 2 wks, prior to starting the enrollment 4. Symptomatic bacterial vaginosis 5. Patients with immune-compromised status due to diseases like Diabetes/ AIDS

Design outcomes

Primary

MeasureTime frame
To determine the effect of administering VSL#3 & Florisia (oral & vaginal probiotic) and placebo on the microflora in females with recurrent UTI.Timepoint: 1 year—

Secondary

MeasureTime frame
To evaluate the reduction in the incidence of symptomatic and probable UTI compared to placebo.Timepoint: 1 year—

Countries

India

Contacts

Public ContactDr Varsha Gupta

Government Medical College & Hospital, Chandigarh

varshagupta_99@yahoo.com919646121571

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026