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

Urinary Tract Infections Clinical Trial

Official title:

Observational Study Evaluating the Number of Symptomatic Cystitis-like Episodes and Urinary Comfort of Women Consuming Cranberry, Cinnamon and Probiotic Strain Extracts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04987164
• Other study ID #: C1671
• Status: Completed
• Start date: November 18, 2021
• Est. completion date: August 4, 2022

Study information

• Verified date: February 2023
• Source: CEN Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 4, 2022
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystitis
• Urinary Tract Infections

Intervention

Dietary Supplement:
• Feminabiane CBU
EXTRACTS OF CRANBERRY, CINNAMON AND MICROBIOTIC STRAINS

Locations

Country	Name	City	State
France	CEN Nutriment	Dijon	Bourgogne
France	CEN Nutriment	Dijon	Burgundy

Sponsors (2)

Lead Sponsor	Collaborator
CEN Biotech	PiLeJe

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessing the remanent effect of the mix on total urinary tract disorders	Total number of urinary tract disorders reported by women, compared to the 0-24 week period	At week 32
Other	Assessing the remanent effect of the mix on the type urinary tract disorders	Rates of urinary tract disorders (cystitis and cystitis-like symptoms) reported by women, compared to the 0-24 week period	At week 32
Other	Satisfaction with the assessed mix	Mean statisfaction score using a 5-point Likert scale: 1 means worse satisfaction and 5 means the best satisfaction.; Very satisfied=1, Somewhat satisfied=2, Neither satisfied nor dissatisfied=3, Somewhat dissatisfied=4 and Very dissatisfied=5	At month 1, 2, 3, 4, 5, 6
Other	Dietary supplementation ingestion observance	Weekly number of food supplements not ingested in relation to the expected consumption	At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Other	Gastrointestinal pain	Visual analogic score assessing abdominal pain (0= no pain, 10= worse pain)	At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Other	Gastrointestinal discomfort	Visual analogic score assessing bloating or flatulence (0= never, 10= always)	At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Other	Assessing tolerance to the ingestion of food supplements	Total number encountered of adverse events (abdominal pain, bloating, constipation) and rates of this adverse events	At week 24
Primary	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	Change of the quality of life related to urinary discomfort	ACCS "Quality of life" domain ranged between 0 (better) and 9 (worse)	At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Secondary	Severity of urinary discomfort	Global ACCS score ranged between 0 (better) and 39 (worse)	Every day during each urinary symptoms (Week 0 to Week 24)
Secondary	Time-period without antibiotics	Measurement of the time interval between 2 antibiotic therapies if applicable	At week 24
Secondary	Mean time to onset of symptomatic episodes of the cystitis	Measurement of the time interval between 2 symptomatic episodes of the cystitis	At week 24
Secondary	Effect of blend consumption in preventing symptomatic episode of cystitis	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).	At week 24