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Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection in Adult Women
NA trial testing Probiotic in Recurrent Urinary Tract Infection in Adult Women in 140 participants. Completed in 12 July 2019.
| Lead sponsor | BioGaia AB |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 140 |
| Start date | 13 December 2017 |
| Primary completion | 12 July 2019 |
| Estimated completion | 12 July 2019 |
| Sites | 1 location across Sweden |
BioGaia AB — full company profile →
Adults 18 to 50, female only, with Recurrent Urinary Tract Infection in Adult Women. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean number (Standard Deviation) of confirmed UTIs in adult women with recurrent UTI, during six months from start of intervention, as compared to placebo.
| Group | Value | 95% CI |
|---|---|---|
| Active | 1.2 | ± 1.4 |
| Placebo | 1.3 | ± 1.3 |
Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Active | Placebo |
|---|---|---|---|
| Concussion | Injury, poisoning and procedural complications | — | — |
| Spontaneous miscarriage | Pregnancy, puerperium and perinatal conditions | — | — |
| Endometritis | Infections and infestations | — | — |
| Reaction | System | Active | Placebo |
|---|---|---|---|
| Nasopharyngitis | Infections and infestations | — | — |
| Headache | Nervous system disorders | — | — |
| Pyrexia | General disorders | — | — |
| Migraine | Nervous system disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| vulvovaginal candidiasis | Infections and infestations | — | — |
| Gastroenteritis | Gastrointestinal disorders | — | — |
| Vulvovaginal mycotic infection | Infections and infestations | — | — |
| Dysmenorrhea | Reproductive system and breast disorders | — | — |
| Conjunctivitis allergic | Eye disorders | — | — |
| Dust Allergy | Immune system disorders | — | — |
| Toothache | Gastrointestinal disorders | — | — |
| Seasonal allergy | Immune system disorders | — | — |
| Urine odour abnormal | Renal and urinary disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Procedural pain | Injury, poisoning and procedural complications | — | — |
| Worsening post surgical pain | General disorders | — | — |
| abdominal pain upper | Gastrointestinal disorders | — | — |
| Influenza | Infections and infestations | — | — |
| abdominal distension | Gastrointestinal disorders | — | — |
| radius fracture | Injury, poisoning and procedural complications | — | — |
| Sinusitis | Infections and infestations | — | — |
| Ligament sprain | Injury, poisoning and procedural complications | — | — |
| Tonsillitis | Infections and infestations | — | — |
| Toe infection | Infections and infestations | — | — |
| head injury | Injury, poisoning and procedural complications | — | — |
| Pneumonia | Infections and infestations | — | — |
| Hypertension | Vascular disorders | — | — |
| Vaginosis bacterial | Infections and infestations | — | — |
| Borrelia | Infections and infestations | — | — |
| blood thyroid stimulating hormone increased | Endocrine disorders | — | — |
| Vaginal Discharge | Reproductive system and breast disorders | — | — |
| musculosceletal pain | Musculoskeletal and connective tissue disorders | — | — |
| nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Skin infection | Infections and infestations | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — |
| abortion spontaneous | Reproductive system and breast disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| dysfunctional uterine bleeding | Reproductive system and breast disorders | — | — |
| Endometritis | Reproductive system and breast disorders | — | — |
Most-reported serious reactions: Concussion, Spontaneous miscarriage, Endometritis.
Data from ClinicalTrials.gov NCT03366077 adverse events section.
Urinary tract infections (UTIs) are the most common bacterial infections in women, with about 50% of women experiencing at least one UTI in their lifetime. The main pharmacological treatments of cystitis usually involve the use of antibiotics, in particular quinolones (such as ciprofloxacin and levofloxacin), fosfomycin, second-generation and third-generation cephalosporins, and b-lactam antibiotics associated with b-lactamase inhibitors.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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