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

CEN Biotech

Status

Completed

Conditions

Urinary Tract Infections

Cystitis

Treatments

Dietary Supplement: Feminabiane CBU

Study type

Observational

Funder types

Industry

Identifiers

NCT04987164

C1671

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.