Incidence of Cystitis in Women Consuming a Mixture of Cranberry, Cinnamon, Probiotics
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Feminabiane CBU Consumers 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
EXTRACTS OF CRANBERRY, CINNAMON AND MICROBIOTIC STRAINS
|
| Control group Control group of non consumers of Feminabiane CBU |
Outcome Measures
Primary Outcome Measures
- Occurence of symptomatic cystitis-like episodes [At week 24]
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.
Secondary Outcome Measures
- Change of the quality of life related to urinary discomfort [At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24]
ACCS "Quality of life" domain ranged between 0 (better) and 9 (worse)
- Severity of urinary discomfort [Every day during each urinary symptoms (Week 0 to Week 24)]
Global ACCS score ranged between 0 (better) and 39 (worse)
- Time-period without antibiotics [At week 24]
Measurement of the time interval between 2 antibiotic therapies if applicable
- Mean time to onset of symptomatic episodes of the cystitis [At week 24]
Measurement of the time interval between 2 symptomatic episodes of the cystitis
- Effect of blend consumption in preventing symptomatic episode of cystitis [At week 24]
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).
Other Outcome Measures
- Assessing the remanent effect of the mix on total urinary tract disorders [At week 32]
Total number of urinary tract disorders reported by women, compared to the 0-24 week period
- Assessing the remanent effect of the mix on the type urinary tract disorders [At week 32]
Rates of urinary tract disorders (cystitis and cystitis-like symptoms) reported by women, compared to the 0-24 week period
- Satisfaction with the assessed mix [At month 1, 2, 3, 4, 5, 6]
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
- Dietary supplementation ingestion observance [At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24]
Weekly number of food supplements not ingested in relation to the expected consumption
- Gastrointestinal pain [At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24]
Visual analogic score assessing abdominal pain (0= no pain, 10= worse pain)
- Gastrointestinal discomfort [At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24]
Visual analogic score assessing bloating or flatulence (0= never, 10= always)
- Assessing tolerance to the ingestion of food supplements [At week 24]
Total number encountered of adverse events (abdominal pain, bloating, constipation) and rates of this adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
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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) ;
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Whose symptomatic episodes of cystitis over the past 6 months have had a significant impact on quality of life / urinary comfort (ACSS QoL> 2);
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Having a smartphone compatible with the NURSTRIAL® data collection application;
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Not opposing the collection and processing of their personal data.
Exclusion Criteria:
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Presenting urinary discomfort with a severe impact on quality of life (ACSS QoL> 7) during the last 24 hours prior to inclusion;
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Pregnant, breastfeeding or planning to become pregnant during the study;
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Under antibiotic treatment (or during the last month preceding inclusion);
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Under food supplementation with prebiotics or probiotics or having stopped it less than a month before inclusion;
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Having had recourse to a prophylactic treatment (cranberry juice) 15 days before inclusion;
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Having had local estrogen therapy during the 3 months preceding inclusion;
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Diabetic;
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Presenting an immunosuppressive disease;
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Presenting pelvic floor abnormalities (Cystocele surgery, etc.);
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Presenting or having a history of kidney disease (including kidney stones, urinary tract abnormalities, pyelonephritis, kidney failure, kidney transplantation);
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For women consuming supplementation: known allergy to plants of the cranberry family or to one of the components of the products.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CEN Nutriment | Dijon | Bourgogne | France | 21000 |
| 2 | CEN Nutriment | Dijon | Burgundy | France | 21000 |
Sponsors and Collaborators
- CEN Biotech
- PiLeJe
Investigators
- Principal Investigator: JEAN-MARC BOHBOT, MD, Institut Fournier-PARIS
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C1671