Clinical trial NCT04987164: Incidence of Cystitis in Women Consuming a Mixture of Cranberry, Cinnamon, Probiotics
Official title: Observational Study Evaluating the Number of Symptomatic Cystitis-like Episodes and Urinary Comfort of Women Consuming Cranberry, Cinnamon and Probiotic Strain Extracts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystitis
Urinary Tract Infections
Lead sponsor: CEN Biotech
Sponsor class: INDUSTRY
Collaborators: name: PiLeJe
First posted: 2021-08-03
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Occurence of symptomatic cystitis-like episodes
timeFrame: At week 24
Secondary outcomes:
measure: Change of the quality of life related to urinary discomfort
timeFrame: At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
measure: Severity of urinary discomfort
timeFrame: Every day during each urinary symptoms (Week 0 to Week 24)
measure: Time-period without antibiotics
timeFrame: At week 24
measure: Mean time to onset of symptomatic episodes of the cystitis
timeFrame: At week 24
measure: Effect of blend consumption in preventing symptomatic episode of cystitis
timeFrame: At week 24
Other outcomes:
measure: Assessing the remanent effect of the mix on total urinary tract disorders
timeFrame: At week 32
measure: Assessing the remanent effect of the mix on the type urinary tract disorders
timeFrame: At week 32
measure: Satisfaction with the assessed mix
timeFrame: At month 1, 2, 3, 4, 5, 6
measure: Dietary supplementation ingestion observance
timeFrame: At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
measure: Gastrointestinal pain
timeFrame: At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
measure: Gastrointestinal discomfort
timeFrame: At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
measure: Assessing tolerance to the ingestion of food supplements
timeFrame: At week 24
Locations:
city: Dijon
country: France
facility: CEN Nutriment
state: Bourgogne
city: Dijon
country: France
facility: CEN Nutriment
state: Burgundy
Study officials:
affiliation: Institut Fournier-PARIS
name: JEAN-MARC BOHBOT, MD
role: PRINCIPAL_INVESTIGATOR
References: