Feminabiane CBU
Dietary SupplementEXTRACTS OF CRANBERRY, CINNAMON AND MICROBIOTIC STRAINS
NCT Number: NCT04987164
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.
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Notify Me18 year–65 year
Female
Observational
CEN Nutriment, Dijon, Bourgogne-Franche-Comté, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EXTRACTS OF CRANBERRY, CINNAMON AND MICROBIOTIC STRAINS
Time frame: 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.
Time frame: 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)
Time frame: Every day during each urinary symptoms (Week 0 to Week 24)
Global ACCS score ranged between 0 (better) and 39 (worse)
Time frame: At week 24
Measurement of the time interval between 2 antibiotic therapies if applicable
Time frame: At week 24
Measurement of the time interval between 2 symptomatic episodes of the cystitis
Time frame: 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).
Time frame: At week 32
Total number of urinary tract disorders reported by women, compared to the 0-24 week period
Time frame: At week 32
Rates of urinary tract disorders (cystitis and cystitis-like symptoms) reported by women, compared to the 0-24 week period
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: At week 24
Total number encountered of adverse events (abdominal pain, bloating, constipation) and rates of this adverse events
CEN Biotech
Industry
Observational Study Evaluating the Number of Symptomatic Cystitis-like Episodes and Urinary Comfort of Women Consuming Cranberry, Cinnamon and Probiotic Strain Extracts
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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