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| Name | Class |
|---|---|
| PiLeJe | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feminabiane CBU Consumers | Group of consumers of Feminabiane CBU : 2 tablets of Feminabiane CBU® every day, to be swallowed with a glass of water. |
| |
| Control group | Control group of non consumers of Feminabiane CBU |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feminabiane CBU | Dietary Supplement | EXTRACTS OF CRANBERRY, CINNAMON AND MICROBIOTIC STRAINS |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the remanent effect of the mix on total urinary tract disorders | Total number of urinary tract disorders reported by women, compared to the 0-24 week period | At week 32 |
| Assessing the remanent effect of the mix on the type urinary tract disorders |
Inclusion Criteria:
Exclusion Criteria:
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The first 80 women of the CEN Nutriment (Clinical Investigation Center) volunteer panel corresponding to the selection criteria and wishing to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| JEAN-MARC BOHBOT, MD | Institut Fournier-PARIS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEN Nutriment | Dijon | Bourgogne-Franche-Comté | 21000 | France | ||
| CEN Nutriment |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39791583 | Derived | Ait Abdellah S, Leblanc A, Dauchet Q, Blondeau C, Bohbot JM. Effects of a supplement associating Lactobacillus strains and proanthocyanidin-rich plant extracts against recurrent uncomplicated, urinary tract infections: A prospective, controlled study. Investig Clin Urol. 2025 Jan;66(1):36-46. doi: 10.4111/icu.20240092. |
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| ID | Term |
|---|---|
| D003556 | Cystitis |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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 |
Rates of urinary tract disorders (cystitis and cystitis-like symptoms) reported by women, compared to the 0-24 week period
| At week 32 |
| Satisfaction with the assessed mix | Mean statisfaction score using a 5-point Likert scale: 1 means worse satisfaction and 5 means the best satisfaction. Very satisfied=1, Somewhat satisfied=2, Neither satisfied nor dissatisfied=3, Somewhat dissatisfied=4 and Very dissatisfied=5 | At month 1, 2, 3, 4, 5, 6 |
| Dietary supplementation ingestion observance | Weekly number of food supplements not ingested in relation to the expected consumption | At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 |
| Gastrointestinal pain | Visual analogic score assessing abdominal pain (0= no pain, 10= worse pain) | At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 |
| Gastrointestinal discomfort | Visual analogic score assessing bloating or flatulence (0= never, 10= always) | At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 |
| Assessing tolerance to the ingestion of food supplements | Total number encountered of adverse events (abdominal pain, bloating, constipation) and rates of this adverse events | At week 24 |
| Dijon |
| Burgundy |
| 21000 |
| France |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007239 | Infections |