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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.
This is a double-blinded, randomized, placebo-controlled, parallel-group study evaluating the effect of the probiotic on recurrent urinary tract infection (UTI) in adult women recently treated for UTI.
Primary objective The primary objective is to evaluate the effect of oral supplementation with probiotic on the frequency of UTI during six months from start of intervention in adult women with recurrent UTI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | L reuteri |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Probiotic |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the Frequency of Confirmed UTI in Adult Women With Recurrent UTI. | Mean number (Standard Deviation) of confirmed UTIs in adult women with recurrent UTI, during six months from start of intervention, as compared to placebo. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the -Frequency of Confirmed UTI -Time to First Relapse of UTI. -Relapse Rate -Assess the Tolerability | Mean number of confirmed UTIs during the three months intervention period, as compared to placebo. Mean number of confirmed UTIs during the three months follow-up period, as compared to placebo. Mean time from start of intervention to first relapse of UTI, as compared to placebo. Proportion of subjects (%) who experienced at least one confirmed UTI during three months from start of intervention, as compared to placebo. Proportion of subjects (%) who experienced at least one confirmed UTI during six months from start of intervention, as compared to placebo. Occurrence and frequency of Adverse Events (AEs). |
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Inclusion Criteria:
Exclusion Criteria:
Postmenopausal (defined as 12 months of amenorrhoea).
Pregnant or breastfeeding.
Planning to become pregnant during the study.
Irregular menstruations combined with perimenopausal symptoms.
Known hypersensitivity or allergy to any of the components of the test product, or to the comparator (placebo).
Use of spermicide contraceptives including spermicidal condom within three days prior to first IP dose.
History of complicated cystitis, urgency incontinence, recent pyelonephritis, urological and/or gynaecologist abnormalities, immunocompromised, as judged by the Investigator.
Unstable bowel disorder such as diarrhoea, Crohn's disease, ulcerative colitis.
-
Healty women
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| Name | Affiliation | Role |
|---|---|---|
| Erik Rein-Hedin, MD | CTC Clinical Trial Consultants AB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Consultants AB | Uppsala | 752 37 | Sweden |
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One of the participants randomised to the placebo group did not start the intervention, therefore it is a discrepancy between the planned and actual number of started participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | Probiotics |
| FG001 | Placebo | Placebo control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Probiotics |
| BG001 | Placebo | Placebo Control Group |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the Frequency of Confirmed UTI in Adult Women With Recurrent UTI. | Mean number (Standard Deviation) of confirmed UTIs in adult women with recurrent UTI, during six months from start of intervention, as compared to placebo. | Posted | Mean | Standard Deviation | Number of unique UTIs during study | 6 months |
|
6 months
In this study, the IP is a food supplement and not an investigational medicinal product.
However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | L reuteri Probiotic: Probiotic | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concussion | Injury, poisoning and procedural complications | Systematic Assessment | Concussion with brief loss of consciousness. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migraine | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jenny Palming Clinical research Director | BioGaia AB | +46 738299900 | jp@biogaia.se |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 24, 2017 | Dec 16, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 3, 2019 | Dec 16, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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double-blinded, randomized, placebo-controlled, parallel-group
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| 6 month |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| weight | Mean | Standard Deviation | kg |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Secondary | To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the -Frequency of Confirmed UTI -Time to First Relapse of UTI. -Relapse Rate -Assess the Tolerability | Mean number of confirmed UTIs during the three months intervention period, as compared to placebo. Mean number of confirmed UTIs during the three months follow-up period, as compared to placebo. Mean time from start of intervention to first relapse of UTI, as compared to placebo. Proportion of subjects (%) who experienced at least one confirmed UTI during three months from start of intervention, as compared to placebo. Proportion of subjects (%) who experienced at least one confirmed UTI during six months from start of intervention, as compared to placebo. Occurrence and frequency of Adverse Events (AEs). | Not Posted | 6 month | Participants |
| 70 |
| 0 |
| 70 |
| 36 |
| 70 |
| EG001 | Placebo | Placebo Probiotic: Probiotic | 0 | 69 | 3 | 69 | 36 | 69 |
|
| Spontaneous miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Abortion spontaneous |
|
| Endometritis | Infections and infestations | Systematic Assessment | Endometritis |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | Systematic Assessment |
|
| Dust Allergy | Immune system disorders | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | Systematic Assessment |
|
| Urine odour abnormal | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Worsening post surgical pain | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| vulvovaginal candidiasis | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| radius fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | Systematic Assessment |
|
| Toe infection | Infections and infestations | Systematic Assessment |
|
| head injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | Systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Vaginosis bacterial | Infections and infestations | Systematic Assessment |
|
| Borrelia | Infections and infestations | Systematic Assessment |
|
| blood thyroid stimulating hormone increased | Endocrine disorders | Systematic Assessment |
|
| Vaginal Discharge | Reproductive system and breast disorders | Systematic Assessment |
|
| musculosceletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin infection | Infections and infestations | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| abortion spontaneous | Reproductive system and breast disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| dysfunctional uterine bleeding | Reproductive system and breast disorders | Systematic Assessment |
|
| Endometritis | Reproductive system and breast disorders | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Vaginal odour | Reproductive system and breast disorders | Systematic Assessment |
|
| Urethritis | Infections and infestations | Systematic Assessment |
|
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| D019602 |
| Food and Beverages |