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

NCT04987164 | Completed

• 1 other identifier: C1671
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Cystitis; Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Occurence of symptomatic cystitis-like episodes

  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.

  At week 24

Secondary Outcomes (5)

• 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

• Severity of urinary discomfort

  Every day during each urinary symptoms (Week 0 to Week 24)

• Time-period without antibiotics

  At week 24

• Mean time to onset of symptomatic episodes of the cystitis

  At week 24

• Effect of blend consumption in preventing symptomatic episode of cystitis

  At week 24

Other Outcomes (7)

• Assessing the remanent effect of the mix on total urinary tract disorders

  At week 32

• Assessing the remanent effect of the mix on the type urinary tract disorders

  At week 32

• Satisfaction with the assessed mix

  At month 1, 2, 3, 4, 5, 6

Study Arms (2)

Feminabiane CBU Consumers

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

Dietary Supplement: Feminabiane CBU

Control group

Control group of non consumers of Feminabiane CBU

Interventions

Feminabiane CBU DIETARY_SUPPLEMENT

EXTRACTS OF CRANBERRY, CINNAMON AND MICROBIOTIC STRAINS

Feminabiane CBU Consumers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The first 80 women of the CEN Nutriment (Clinical Investigation Center) volunteer panel corresponding to the selection criteria and wishing to participate in the study.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant, breastfeeding or planning to become pregnant during the study;
• 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.

Sponsors & Collaborators

• CEN Biotech: lead
• PiLeJe: collaborator

Study Sites (2)

CEN Nutriment

Dijon, Bourgogne-Franche-Comté, 21000, France

Location

CEN Nutriment

Dijon, Burgundy, 21000, France

Location

Related Publications (1)

• 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.

  PMID: 39791583 DERIVED

MeSH Terms

Conditions

Cystitis; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections

Study Officials

• JEAN-MARC BOHBOT, MD

  Institut Fournier-PARIS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 3, 2021
• Study Start: November 18, 2021
• Primary Completion: August 4, 2022
• Study Completion: August 4, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

FR (2)