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
NCT number | NCT04987164 |
Other study ID # | C1671 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 18, 2021 |
Est. completion date | August 4, 2022 |
Verified date | February 2023 |
Source | CEN Biotech |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | CEN Nutriment | Dijon | Bourgogne |
France | CEN Nutriment | Dijon | Burgundy |
Lead Sponsor | Collaborator |
---|---|
CEN Biotech | PiLeJe |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04495699 -
Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections
|
||
Terminated |
NCT05254808 -
EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care
|
Phase 3 | |
Completed |
NCT03680612 -
Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI
|
Phase 2 | |
Completed |
NCT03282006 -
Treating Pyelonephritis an Urosepsis With Pivmecillinam
|
Phase 4 | |
Completed |
NCT03526484 -
The Utility of Urinalysis Prior to In-Office Procedures
|
N/A | |
Completed |
NCT05397782 -
Effects of Flourish on Recurrent Urinary Tract Infection
|
N/A | |
Completed |
NCT05018546 -
Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery
|
N/A | |
Completed |
NCT03687255 -
Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections
|
Phase 3 | |
Recruiting |
NCT05227937 -
Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study
|
||
Completed |
NCT02864420 -
Hospitalization at Home: The Acute Care Home Hospital Program for Adults
|
N/A | |
Completed |
NCT03131609 -
Avoiding Bacterial Contamination of Clean Catch Urine Cultures in Ambulatory Patients in the Emergency Department
|
||
Completed |
NCT01911143 -
A Retrospective, Blinded Validation of a Host-response Based Diagnostics
|
N/A | |
Completed |
NCT01333254 -
A Trial of Different Methods for Bladder Drainage in Hip Surgery Patients
|
N/A | |
Terminated |
NCT00594594 -
Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord Injury
|
Phase 1 | |
Completed |
NCT00216853 -
A Study of Vaginal MicroFlora and Immune Profiles of Patients With Recurrent Urinary Tract Infection
|
N/A | |
Completed |
NCT00787085 -
The Significance of Funguria in Hospitalized Patients
|
N/A | |
Completed |
NCT05719753 -
The Effectiveness of a Bacteriophobic Coating on Urinary Catheters
|
N/A | |
Recruiting |
NCT05415865 -
The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder
|
Phase 3 | |
Not yet recruiting |
NCT05880329 -
DIagnoSing Care hOme UTI Study
|
||
Recruiting |
NCT04615065 -
Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
|