Incidence of Cystitis in Women Consuming a Mixture of Cranberry, Cinnamon, Probiotics

Study Overview
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Brief Summary
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Cranberries are traditionally used for urinary comfort and prevention of urinary disorders of bacterial origin and despite an EFSA opinion invalidating the clinical efficacy of cranberries, its mechanism of action has been several times proposed by the scientific community: it would act by inhibiting the synthesis of P-fimbriae leading to a complete disappearance of these adhesins, and to bacterial-type deformation by lengthening of the cell body. Cinnamon and microbiotic strains could enhance this synergy. This study aims to evaluate the effectiveness of a food supplement based on cranberry, cinnamon and microbiotic strains (Feminabiane CBU) on the symptoms of cystitis, urinary discomfort and the number of cystitis reported by women.

Detailed Description
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Women who use or not the cranberry, cinnamon, and microbiotic blend are encouraged to complete a 6-month diary in which they report any urinary tract disorders they encounter.

Official Title
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Observational Study Evaluating the Number of Symptomatic Cystitis-like Episodes and Urinary Comfort of Women Consuming Cranberry, Cinnamon and Probiotic Strain Extracts

Conditions
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Cystitis, Urinary Tract Infections

Intervention / Treatment
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* Dietary Supplement: Feminabiane CBU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having at least 2 symptomatic episodes of cystitis during the last 6 months including at least 1 episode confirmed as being bacterial cystitis (by an urine bacterial analysis or validated by a doctor (date of appointment, list of prescribed treatments) ; Whose symptomatic episodes of cystitis over the past 6 months have had a significant impact on quality of life / urinary comfort (ACSS QoL> 2); Having a smartphone compatible with the NURSTRIAL® data collection application; Not opposing the collection and processing of their personal data. Exclusion Criteria: Presenting urinary discomfort with a severe impact on quality of life (ACSS QoL> 7) during the last 24 hours prior to inclusion; Pregnant, breastfeeding or planning to become pregnant during the study; Under antibiotic treatment (or during the last month preceding inclusion); Under food supplementation with prebiotics or probiotics or having stopped it less than a month before inclusion; Having had recourse to a prophylactic treatment (cranberry juice) 15 days before inclusion; Having had local estrogen therapy during the 3 months preceding inclusion; Diabetic; Presenting an immunosuppressive disease; Presenting pelvic floor abnormalities (Cystocele surgery, etc.); Presenting or having a history of kidney disease (including kidney stones, urinary tract abnormalities, pyelonephritis, kidney failure, kidney transplantation); For women consuming supplementation: known allergy to plants of the cranberry family or to one of the components of the products.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Feminabiane CBU Consumers<br>Group of consumers of Feminabiane CBU : 2 tablets of Feminabiane CBU® every day, to be swallowed with a glass of water. | Dietary Supplement: Feminabiane CBU<br>* EXTRACTS OF CRANBERRY, CINNAMON AND MICROBIOTIC STRAINS<br>|
| Control group<br>Control group of non consumers of Feminabiane CBU | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of symptomatic cystitis-like episodes | Number of symptomatic cystitis-like episodes reported by the subject self-assessed using the typical domain of the Acute Cystitis Symptom Score (ACCS) and defined by a score ranged between 6 to 18. | At week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the quality of life related to urinary discomfort | ACCS Quality of life domain ranged between 0 (better) and 9 (worse) | At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | 
| Severity of urinary discomfort | Global ACCS score ranged between 0 (better) and 39 (worse) | Every day during each urinary symptoms (Week 0 to Week 24) | 
| Time-period without antibiotics | Measurement of the time interval between 2 antibiotic therapies if applicable | At week 24 | 
| Mean time to onset of symptomatic episodes of the cystitis | Measurement of the time interval between 2 symptomatic episodes of the cystitis | At week 24 | 
| Effect of blend consumption in preventing symptomatic episode of cystitis | Comparison of the rate of women blend users versus non-users who did not reported any symptomatic episode of cystitis as defined by a 0 score for the typical domain of the Acute Cystitis Symptom Score (ACCS). | At week 24 |