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

Completed

• Conditions: Cystitis; Urinary Tract Infections
• Interventions: Dietary Supplement: Feminabiane CBU

• Registration Number: NCT04987164
• Lead Sponsor: CEN Biotech

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.

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 Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-23
• Study First Posted: 2021-08-03
• Study Start: 2021-11-18
• Primary Completion: 2022-08-04
• Study Completion: 2022-08-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Feminabiane CBU Consumers	Feminabiane CBU	Group of consumers of Feminabiane CBU : 2 tablets of Feminabiane CBU® every day, to be swallowed with a glass of water.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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

Trial Locations

Locations (1)

CEN Nutriment; 🇫🇷 Dijon, Burgundy, France