Health Condition 1: N390- Urinary tract infection, site notspecified
Conditions
Interventions
Intervention1: DAPAD Complex sachets, dietary supplement containing D-mannose, plant extracts and prebiotic fibres.: 2 sachets a day (Morning & Evening) dissolved in a glass of water (150 ml) and mix
Sponsors
Giellepi SpA
Eligibility
Inclusion criteria
Inclusion criteria: Adult Female Fertile age Age � 18 years to 45 years Written informed consent At least one of four key UTI symptoms that could be attributed to an uncomplicated UTI, and no alternative explanation (i.e. symptoms suggestive of STI or vulvo-vaginitis): Dysuria Urgency (including nocturia) Frequency Suprapubic tenderness Urine culture positive for E.Coli �105 cfu/mL
Exclusion criteria
Exclusion criteria: 1. Male sex 2. Urine culture positive to uropathogens different from E. coli 3. Pregnancy or planned pregnancy 4. Concomitant antimicrobial therapy at the time of screening 5. Use of any antibiotics in the past 7 days 6. Use of dietary supplements (such as cranberry, probiotics, etc) during the month before recruitment 7. Known or suspected hypersensitivity or allergy to any ingredient of Investigational product 8. Active upper UTI (e.g. pyelonephritis, urosepsis: fever > 38.0, flank pain, chills) 9. Symptoms/signs suggestive of vaginitis or sexually transmitted infection 10. Indwelling catheter, nephrostomy, ureter stent or other foreign material 11. Otherwise complicated UTI: � A history of anatomical or functional abnormalities of the urogenital tract: � Congenital abnormalities � Polycystic kidney disease � Obstruction or stricture of renal pelvis, ureter or urethra � Kidney stones � Cystocele � Cystic diverticulae � Change of anatomical proportions (e.g. after ureter implantation) � Chronic vesico-urethral reflux � Neurogenic bladder 12. Severe chronic renal (creatinine clearance 13. Diagnosis of diabetes 14. Immunosuppression: � Untreated infection with the human immunodeficiency virus (HIV) � Use of high-dose systemic corticosteroids or other immunosuppressive medication � Chemotherapy � Treatment with radiation 15. Critical illness requiring intensive care 16. Planned surgery within the next 6 weeks 17. Pelvic or gynecological surgery during the 6 months before recruitment 18. Inability to take oral drugs 19. Participation in another prospective clinical trial 20. Previous enrolment in the proposed study 21. Inability to understand or to follow the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical response at the end of treatment (day 6 Ã?±2 days) and one month after the end of therapy.Timepoint: (day 6 Ã?±2 days) and one month after the end of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| bacteriologic response at the end of therapyTimepoint: day 6 Ã?±2 days and one month after the end of therapy | — |
Countries
India
Contacts
Public ContactMs Divya Chandradhara
BioAgile Therapeutics Pvt Ltd
Outcome results
None listed