- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04987164
Incidence of Cystitis in Women Consuming a Mixture of Cranberry, Cinnamon, Probiotics
Observational Study Evaluating the Number of Symptomatic Cystitis-like Episodes and Urinary Comfort of Women Consuming Cranberry, Cinnamon and Probiotic Strain Extracts
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Bourgogne
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Dijon, Bourgogne, France, 21000
- CEN Nutriment
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Burgundy
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Dijon, Burgundy, France, 21000
- CEN Nutriment
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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.
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EXTRACTS OF CRANBERRY, CINNAMON AND MICROBIOTIC STRAINS
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Control group
Control group of non consumers of Feminabiane CBU
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurence of symptomatic cystitis-like episodes
Time Frame: At week 24
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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.
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At week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of the quality of life related to urinary discomfort
Time Frame: At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
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ACCS "Quality of life" domain ranged between 0 (better) and 9 (worse)
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At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
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Severity of urinary discomfort
Time Frame: Every day during each urinary symptoms (Week 0 to Week 24)
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Global ACCS score ranged between 0 (better) and 39 (worse)
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Every day during each urinary symptoms (Week 0 to Week 24)
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Time-period without antibiotics
Time Frame: At week 24
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Measurement of the time interval between 2 antibiotic therapies if applicable
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At week 24
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Mean time to onset of symptomatic episodes of the cystitis
Time Frame: At week 24
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Measurement of the time interval between 2 symptomatic episodes of the cystitis
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At week 24
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Effect of blend consumption in preventing symptomatic episode of cystitis
Time Frame: At week 24
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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).
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At week 24
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing the remanent effect of the mix on total urinary tract disorders
Time Frame: At week 32
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Total number of urinary tract disorders reported by women, compared to the 0-24 week period
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At week 32
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Assessing the remanent effect of the mix on the type urinary tract disorders
Time Frame: At week 32
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Rates of urinary tract disorders (cystitis and cystitis-like symptoms) reported by women, compared to the 0-24 week period
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At week 32
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Satisfaction with the assessed mix
Time Frame: At month 1, 2, 3, 4, 5, 6
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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
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Dietary supplementation ingestion observance
Time Frame: At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
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Weekly number of food supplements not ingested in relation to the expected consumption
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At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
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Gastrointestinal pain
Time Frame: At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
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Visual analogic score assessing abdominal pain (0= no pain, 10= worse pain)
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At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
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Gastrointestinal discomfort
Time Frame: At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
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Visual analogic score assessing bloating or flatulence (0= never, 10= always)
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At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
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Assessing tolerance to the ingestion of food supplements
Time Frame: At week 24
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Total number encountered of adverse events (abdominal pain, bloating, constipation) and rates of this adverse events
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At week 24
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: JEAN-MARC BOHBOT, MD, Institut Fournier-PARIS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C1671
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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