Health Condition 1: null- Recurrent Urinary Tract Infections
Conditions
Interventions
Intervention1: Bio-Kult Pro-Cyan: Vegetable Capsule two probiotic bacteria (Lactobacillus acidophilus PXN 35, Lactobacillus plantarum PXN 47), cranberry extract (18mg), vitamin A (160mcg).
Administer
Sponsors
Probiotics International Ltd
QED Clinical Services India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female subjects aged >=18 and 2. Subjects who have had at least 2 or more episodes of uncomplicated acute UTIs in last six months or three or more episodes of uncomplicated acute UTIs in last 12 months 3. Willing and able to comply with the requirements of the protocol and available for the planned duration of the study 4. Willing to avoid all supplements and foods that contain cranberries for the duration of the study 5. Willing to avoid all other probiotics supplements for the duration of the study 6. Subject must be surgically sterile prior to participation in trial OR Subjects who are of child bearing potential must be willing to use a suitable and effective contraceptive method for the study duration. Results of the pregnancy test done at screening must be negative and available prior to randomization visit.
Exclusion criteria
Exclusion criteria: 1. Subjects having active UTI 2. Subject is post-menopausal 3. Pregnant or breast-feeding women 4. Women of childbearing potential who have a positive pregnancy test result or do not have their pregnancy test result at baseline 5. Women of childbearing potential who are unwilling to use acceptable contraceptive methods during the course of study. Acceptable methods of contraception include combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal); progesteroneonly hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable); intrauterine device; intra-uterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; sexual abstinence; or male condom in combination with either cap, diaphragm, or sponge with spermicide (double-barrier contraception) 6. Known history of Human Immunodeficiency Virus (HIV) infection 7. Participation in another clinical trial within the last one month prior to entry in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the proportion of subjects with recurrent UTI episodes in the Bio-Kult Pro-Cyan and the Placebo groupsTimepoint: at the end of 26 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To estimate the proportion of subjects with 0, 1, 2 or more UTI episodes â?¢ Number of UTI episodes â?¢ Duration of antibiotic treatment for an acute UTI episodeTimepoint: at the end of 26 weeks of treatment | — |
Countries
India
Contacts
Public ContactAli Sajjad Bohra
QED Clinical Services India Pvt. Ltd.
Outcome results
None listed