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

NCT ID: NCT04987164

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-18
• Study Completion Date: 2022-08-04

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.

Conditions

Cystitis; Urinary Tract Infections

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Feminabiane CBU Consumers

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

Feminabiane CBU

Intervention Type: DIETARY_SUPPLEMENT

EXTRACTS OF CRANBERRY, CINNAMON AND MICROBIOTIC STRAINS

Control group

Control group of non consumers of Feminabiane CBU

No interventions assigned to this group

Interventions

Feminabiane CBU

EXTRACTS OF CRANBERRY, CINNAMON AND MICROBIOTIC STRAINS

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

PiLeJe

INDUSTRY

Sponsor Role: collaborator

CEN Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JEAN-MARC BOHBOT, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Fournier-PARIS

Locations

CEN Nutriment

Dijon, Bourgogne-Franche-Comté, France

CEN Nutriment

Dijon, Burgundy, France

Countries

France

References

Ait Abdellah S, Leblanc A, Dauchet Q, Blondeau C, Bohbot JM. Effects of a supplement associating Lactobacillus strains and proanthocyanidin-rich plant extracts against recurrent uncomplicated, urinary tract infections: A prospective, controlled study. Investig Clin Urol. 2025 Jan;66(1):36-46. doi: 10.4111/icu.20240092.

Reference Type: DERIVED

PMID: 39791583 (View on PubMed)

Other Identifiers

C1671

Identifier Type: -

Identifier Source: org_study_id